ANNUAL REPORT 2019 Annual Report 2019 the Future of Cancer Therapy Table of Content

ANNUAL REPORT 2019 Annual Report 2019 The future of cancer therapy Table of content

Message from EORTC Director General 4

State of cancer 6

EORTC network 10

EORTC tumour & cross-discipline groups 13

EORTC infrastructure projects 49

Our partners 53

Engaging patients 54

Fellowships 58

Events & campaigns 59

EORTC general assembly, board & committees 63

Financials 64

The EORTC cancer research fund (ECRF) 66

Publications and clinical trials 2019 77

3 MESSAGE FROM EORTC DIRECTOR GENERAL

Driving practice-changing clinical research professionals to become future leaders. The that improves survival and quality of life for Early Career Investigator Leadership Programme cancer patients. This is our mission at the is designed to do just that. In 2019, we engaged EORTC, and one that our community that over 30 young clinical investigators to lead EORTC stretches across Europe and indeed around into an even more audacious future in the fight the world are dedicated to achieve. In 2019, against cancer. we reached major milestones to advance our mission that I am proud to share in this After 50 years leading clinical cancer research, annual report. we have observed weaknesses in European healthcare systems that we strongly believe Our scientific output in 2019 was truly phenom- must be addressed to improve patient treatment enal. EORTC enrolled 2 583 patients in trials and survival. This requires political engagement and screened 3 332 more. We opened 10 trials at European levels, which we officially for enrollment, and continued progressing the embarked on in 2019 with the publication of a 57 ongoing trials from our Brussels headquarters. European manifesto for treatment optimisation. The EORTC community published an impressive Together in a coalition with like-minded partners, 67 papers in renowned scientific journals. Our we have begun advocating for reforms at the infrastructure platforms, SPECTA and E²-RADiatE European Parliament that we hope will lead to have continued to flourish. positive change.

When we reflected on our research priorities On behalf of our members, staff and the oncology in 2019, it became clear that we needed to invest community at large, we thank all the generous more in high-quality clinical research in radiation supporters who believe in our mission and oncology. Working with a leading think-tank in contribute financially to our cause. Because of Brussels, we gathered a broad coalition of experts your support through the EORTC Cancer Research to discuss the state of science for radiation Fund (ECRF), we are able to achieve scientific oncology. Three trials emerged from this meeting breakthroughs that turn patients into survivors. that should help to ensure that this discipline remains at the forefront of cancer care.

We believe that staying at the vanguard of clinical Denis Lacombe, MD research requires investing in young healthcare EORTC Director General

4 5 STATE OF CANCER

STATE OF CANCER IN THE WORLD1

Cancer is the first or second leading cause of premature death (ages 30-69 years) in 134 of 183 countries.

1 in 8 men and 1 in 10 women are likely to develop the disease during STATE OF CANCER IN EUROPE their lifetimes. With more than 3.7 million new cases and 1.9 million deaths each year, cancer represents the The predicted global second most important cause of death and morbidity in Europe. cancer burden is expected to exceed 27 million new Although more than 40 per cent of cancer deaths can be prevented, cancer accounts for 20 cancer cases per year per cent of deaths in the European Region. by 2040, a 50 per cent ASR (world) per 100 000 increase on the estimated 315.5 Not applicable Europe comprises only one eighth of the total world population but has around one quarter 18.1 million cancers in 2018. 296.3-315.5 No data of the global total of cancer cases with some 3.7 million new patients per year. 267.5-296.3

1 World Cancer Report 2020 245.8-267.5 Data source: GLOBOCAN 2018 Graph production: IARC < 245.8 World Health Organization *Estimated age-standardised incidence rates (world) in 2018, all cancers, both sexes, all ages.

6 7 “EORTC serves as a crucial Understanding our and independent hub in the clinical research world with mission and purpose its unique global research infrastructure.” Over the past 150 years, medical researchers have made significant headway against cancer. Cancer survival rates are increasing, and cancer patient quality of life is improving. Researchers are focusing more and more on targeted and precision medicine, adapted to individual patients and their individual tumours. In short, cancer survivors are increasingly able to look forward to leading longer, fuller and more normal lives.

Nevertheless, one out of every four women and one out of every three men will face this disease in their lifetime. Even if successfully treated, these In addition, large pragmatic clinical trials FROM THE LAB TO THE BEDSIDE patients will face ongoing long-term survival and addressing patients centered questions are also care challenges. Cancer will remain an urgent crucially needed to establish new therapeutic Founded in 1962 as a non-profit research to a core staff of over 200 at our Brussels office, priority on the global public health agenda. strategies. The European Organisation for organisation, EORTC has long been leading the our network comprises over 930 institutions in Research and Treatment of Cancer is uniquely way in cancer therapy. We play a key role in 30 countries. UNIQUELY POSITIONED TO LEAD positioned to lead these efforts. multi-disciplinary, international translational and clinical research, taking basic science from Ever more ambitious on behalf of the cancer Paradoxically, as researchers develop ever more While the majority of academic institutions and the lab bench to the patient’s bedside. patients whom we ultimately serve, EORTC is precisely targeted cancer treatments, even down research organisations work on a national level working to set the bar higher for research design to the genomic level, the greater the amounts of or on single tumour types, EORTC serves as a Over our history, EORTC has grown its capacity to and global standards of clinical cancer research scientific co-operation they require. Precision crucial, independent and multitumour (including conduct and co-ordinate clinical cancer research, and to ensure greater and deeper co-ordination medicine requires big data and collaboration on rare cancers) hub in the research world with its continuously evolving and adapting its approach amongst research groups and partners. a continental and even global scale. unique global research infrastructure. to reflect the accelerating pace of discovery and progress in cancer therapies, as well as an ever Our work spans tumour types, disciplines, and more complex regulatory framework. Expanding national borders. EORTC specialises in pan- European and international efforts that would be impossible on a national scale. Its synergistic network of institutions offer researchers a transnational research platform with an EORTC practice-changing trials unsurpassed level of quality and efficiency, with Since 1962, EORTC has been conducting large phase III trials that have changed practice improving the a special interest in rare cancers and long-term quality of life and survival of cancer patients. Notable practice changing trials have been conducted in follow-up. EORTC delivers robust data sets and is brain, breast, head and neck, leukemia, sarcoma, melanoma, prostate and rare cancers. committed to generate solid medical evidence.

8 9 EORTC NETWORK

Our clinical research covers all types of cancer We conduct activities through tumour and tumours with an integrated approach to modality oriented research groups. evaluating innovative agents and multimodal therapeutic strategies against current standard Beyond tumour-specific research, our experts of care. examine every aspect of cancer therapy, including pharmacology and molecular mechanisms, Our objective is to find the best solution pathobiology, radiotherapy and imaging. for patients from both an efficacy and quality-of-life perspective.

CUTANEOUS CANCER PATHO- BRAIN BREAST IMAGING LYMPHOMA IN ELDERLY BIOLOGY

PHARMACOLOGY GASTRO GENITO- QUALITY OF ENDOCRINE & MOLECULAR INTESTINAL URINARY LIFE MECHANISMS

GYNECO- HEAD & NECK LEUKEMIA LOGICAL

LUNG LYMPHOMA MELANOMA

SOFT TISSUE & BONES

10 11 EORTC TUMOUR & CROSS-DISCIPLINE GROUPS

“Working with over 5000 clinical researchers across the globe, EORTC drives innovation in cancer”

Bertrand Tombal, EORTC President

12 13 Top results

Final result of INTELLANCE1 indicated a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing after the end of first-line adjuvant temozolomide treatment.

Long-term follow-up results of the CATNON2 trial demonstrated that maintenance temozolomide prolongs survival in patients with IDH mutant, 1p/19q-non-codeleted anaplastic gliomas.

Primary results of G-SAM3, a large cohort study of matched primary and recurrent IDH WT tumours, BRAIN TUMOUR GROUP established the frequency of GBM driver instability after chemoradiotherapy with temozolomide. It identified genes where repeat surgery is necessary due to low mutation retention rate.

Final results of TMT-GLIOMA4 showed that reduced TMT is an independent negative prognostic Mission parameter in patients with progressive glioblastoma. It may help to facilitate patient management by supporting stratification for therapeutic interventions or clinical trials. The Brain Tumour Group initiates and conducts research to challenge, re-define and develop standards of care in controversial areas of diagnostic and therapeutic neuro-oncology. The Group is Final results of Metformin-GBM5 indicated that Metformin did not prolong survival of patients especially focused on diffuse gliomas of adulthood of WHO (World Health Organisation) grades II to with newly diagnosed glioblastoma. Additional studies may identify patients with specific tumour IV and, in recent years, also meningioma. characteristics that are associated with potential benefits from treatment with Metformin.

Final results of EORTC 16546 revealed that low MGMT methylation may confer some sensitivity to temozolomide treatment. Lower safety margins should be considered for selecting patients with unmethylated glioblastoma into trials omitting temozolomide. Leadership 1 INTELLANCE 2: ABT 414 alone or ABT 414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumour Group - EORTC 1410

2 Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON intergroup trial - EORTC- 26053-22054-BTG-ROG

3 Research project: Stability of actionable mutations in glioblastoma - EORTC 1542 (G-SAM)

4 Research project: evaluation of temporal muscle thickness as prognostic parameter in glioma patients: retrospective imaging study in TAVAREC 26091 and EORTC 26101 - EORTC 1664 (TMT-GLIOMA)

5 Research project: associate of metformin use with outcome in IDH1-mutant vs IDH1-Wildtype gliomas of WHO Grades II-IV - EORTC 1663 (Metformin-GBM)

6 Research project: Meta-analysis of the correlation between MGMT promoter methylation data and survival outcome after chemoradiotherapy (TMZ/RT / TMZ) for newly diagnosed glioblastoma - EORTC 1654

Michael Weller Jaap Reijneveld Frédéric Dhermain Chair Secretary Treasurer

Universitätsspital Zürich, Amsterdam University Medical Institut Gustave Roussy, France 10 544 44 Switzerland Centre, The Netherlands trials members new members

15 BREAST CANCER GROUP

Top results Mission Agreed to focus on three research areas (I) older patients in need of greater access to innovation This Group aims to challenge, re-define and develop standards of care in all controversial areas of breast (II) specific populations based on molecularly defined groups and (III) patient-driven research to cancer diagnosis and therapy, including rare conditions such as male breast cancer. The Group researches improve quality of life. long-term outcomes and follows all patients until death. Opened a phase II study of Adjuvant Palbociclib as an alternative to chemotherapy in elderly patients with high-risk ER+/HER2 early breast cancer (APPALACHES).1 If positive, it may be practice-changing for older populations where chemotherapy triggers more side effects. Leadership Closed the first prospective Intergroup Translational Research Trial assessing the potential predictive value of p53.2 Trial used a functional assay in yeast in patients with locally advanced / inflammatory or large operable breast cancer, prospectively randomised to a taxane versus a non taxane regimen.

Finished recruitment of PYTHIA3, a phase II study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2 metastatic breast cancer. The study is molecularly characterised.

Presented quality of life results to benefit HER2+4 metastatic breast cancer population at the International Society for Quality of Life Research. Study showed that the addition of metronomic Etienne Brain Frederieke van Duijnhoven oral cyclophosphamide to trastuzumab plus pertuzumab in older and frail patients with HER2- Chair Secretary positive metastatic breast cancer increased progression-free survival by 7 months. Institut Curie - Hopital Rene The Netherlands Cancer Institute-Antoni Van

Huguenin, France Leeuwenhoekziekenhuis, The Netherlands 1 A phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALA- CHES) - EORTC-1745-ETF-BCG

2 First prospective Intergroup Translational Research Trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane versus a non taxane regimen - EORTC-10994-BCG

3 A phase II study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2- metastatic Breast Cancer; Palbociclib in molecularly characterized ER-Positive/HER2 negative metastatic Breast Study: the PYTHIA study - EORTC-1502-BCG

4 Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH/PHM: an open-label multicentre randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group - EORTC-75111-10114-ETF-BCG

Michail Ignatiadis Kim Aalders

Treasurer Early Career Investigator leader 14 405 58 Institut Jules Bordet, Belgium Ziekenhuis Gelderse Vallei, The Netherlands trials members new members

16 17 CANCER IN ELDERLY TASK FORCE

Mission Top results

Geriatric oncologists have two main challenges: (I) selecting patients for specific treatments and (II) Activated APPALACHES1, a phase II study of Adjuvant Palbociclib as an Alternative to CHemotherapy the delicate balance of prolonging their survival, whilst maintaining independence and quality of life. in Elderly patientS with high-risk ER+/HER2- early breast cancer in conjunction with the breast Since elderly patients are underrepresented in cancer clinical trials, it is hard to have evidence-based cancer group. recommendations in everyday clinical practice. The Group conducts elderly-specific clinical research to meet these two challenges. Published paper on cancer events in Belgian nursing homes based on an EORTC prospective cohort study showing that there are fewer cancers in elderly residents’ homes and less referrals and treatments.2

Leadership Study3 showed that the addition of metronomic oral cyclophosphamide to trastuzumab plus pertuzumab in older and frail patients with HER2-positive metastatic breast cancer increased progression-free survival by seven months.

1 A phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALA- CHES) - EORTC-1745-ETF-BCG

2 Wildiers H., Mauer M., Elseviers M. et al. Cancer events in Belgian nursing home residents: An EORTC prospective cohort study. Journal of Geriatric Onco- logy. 2019; vol. 10; issue 5; p.805-810; doi: 10.1016/j.jgo.2019.03.005 (https://doi.org/10.1016/j.jgo.2019.03.005)

3 This study was originally developed in the EORTC-ESMO-AACR Methods in Clinical Cancer Research Workshop and Phase II results were published in the Lancet Oncology Journal in 2018.

Antonella Brunello Lissandra Dal Lago Andrea Luciani

Chair Secretary & Early Career Treasurer Istituto Oncologico Veneto IRCCS, Investigator leader Ospedale San Paolo, 3 177 20 Italy Institut Jules Bordet, Belgium Italy trials members new members

18 19 CUTANEOUS LYMPHOMA TASK FORCE Mission

Cutaneous lymphomas are rare cancers that require a widely-distributed, multidisciplinary network to effectively study. Operating as a task force, the Group is focused on testing new agents in collaboration with industry and translational researchers. They regularly engage in prospective research for prognostic index development.

Leadership

Top results

Further defined clinicopathological characteristics of distinct types of cutaneous lymphomas, establishing new standard of care treatments.

Involved more patients in protocol reviewing processes in the UK. Julia Scarisbrick Antonio Cozzo Chair Secretary Grew the Early Career Investigator Programme to a total of 51 future leaders in cutaneous University Hospitals Birmingham NHS Kantonsspital St Gallen, Switzerland lymphoma research. Foundation Trust (UHB) - Queen Elizabeth

Medical Centre, United Kingdom The Group’s Athens meeting was attended by almost 250 participants from Europe, the United States, Canada, Australia and Japan. The scientific programme was even more inclusive than previous meetings with 11 distinct sessions and 123 presentations.

Joined the International Rare Cancer Initiative (IRCI) in association with the International Society of Cutaneous Lymphomas.

Evangelina Papadavid Emmanuella Guenova

Treasurer Early Career Investigator leader 2 195 9 Athens University - Attikon University Lausanne University Hospital (CHUV), trials members new members General, Greece Switzerland

20 21 ENDOCRINE TUMOUR GROUP

Mission

The newly formed Endocrine Group engages in translational research to reduce the burden of cancer from endocrine organs, in particular the thyroid. Members are especially focused on identifying novel treatment options for aggressive forms of thyroid carcinoma (TC) and reducing the disease burden by minimising management in high-prevalent low-risk TC. Top results

Led a strategy meeting where members identified three priority areas for translational research: (I) novel treatment options for aggressive forms of thyroid carcinoma, (II) reducing disease burden by minimising management for high-prevalent low risk patients and (III) improving quality of life. Leadership Members committed to build and maintain an open collaborative platform where everyone takes responsibility for the Group’s viability, the development of novel research and the distribution of knowledge.

Members are pursuing projects that enable interdisciplinary collaboration across EORTC and with partner organisations and pharmaceutical companies.

The Group initiated six investigator initiated study proposals and is exploring three more.

Johannes Smit Laura Locati Sophie Leboulleux Chair Secretary Treasurer Radboud University Medical Fondazione IRCCS Istituto Nazionale Institut Gustave Roussy, France 1 178 36 Center Nijmegen, dei Tumouri, Italy trials members new members The Netherlands

22 23 GASTROINTESTINAL TRACT CANCER GROUP Mission

This Group focuses on expanding what we know about the genetic, epigenetic and immunologic backgrounds of gastrointestinal tumour diseases. Clinical trials focus on preclinical to clinical interaction and integrating early drug development, ensuring that new aspects of tumour biology are investigated with appropriate technology.

Leadership Top results

Initiated CRUCIAL1 to assess the feasibility and safety of adding immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant chemoradiation therapy in inoperable patients with early or locally advanced oesophageal cancer.

Initiated VESTIGE2 to investigate whether nivolumab plus ipilimumab given as adjuvant treatment will improve survival. Trial patients have stage Ib-IVa gastric and esophagogastric junction adenocarcinoma with a high risk of recurrence following neoadjuvant chemotherapy and resection.

Initiated two new Early Career Investigator projects: (I) Early Onset Colorectal Cancer and (II) Liver Florian Lordick Elizabeth Smyth Metastases of Gastric Cancer. Chair Secretary

University Cancer Center Leipzig, Germany Cambridge University Hospital NHS - Formed a new colorectal cancer task force with Marc Peeters as the supervisory senior speaker Addenbrookes Hospital, United Kingdom and Thibault Kössler and Francesco Sclafani as spokespeople.

Increased participation in Group meetings with over 100 participants at the latest Tallinn conference in October 2019.

1 Phase II trial in inoperable œsophageal cancer evaluating the feasibility of the combination of definitive chemoradiation with the immune checkpoint blockers Nivolumab +/- Ipilimumab (CRUCIAL) - EORTC-1714-ROG-GITCG

2 Adjuvant immunotherapy in patients with resected gastric cancer following preoperative chemotherapy with high risk for recurrence (N+ and/or R1): an open label randomized controlled phase-2-study (VESTIGE) - EORTC-1707-GITCG

Theo Ruers Elisa Fontana

Treasurer Early Career Investigator leader 12 639 74 The Netherlands Cancer Institute-Antoni Van Institute Of Cancer Research, trials members new members Leeuwenhoekziekenhuis, The Netherlands United Kingdom

24 25 GENITO-URINARY CANCERS GROUP Top results Joined IMMUcan1, a more than 30 million Euro funded biomarker project involving various types of cancer using the EORTC’s SPECTA platform, which uses 400 treatment-naive metastatic renal cell carcinomas (RCC). Mission Submitted three proposals including to develop a RCC specific quality-of-life instrument and a This Group focuses on treating cancers of the urinary tract and male reproductive system. They are randomised trial of deferred cytoreductive nephrectomy in synchronous metastatic RCC receiving especially concentrated on clinical research for prostate cancer. Members are also interested in rarer checkpoint inhibitors. diseases and biomarker-driven research. Cooperated with POUT22 on their randomised trial of adjuvant chemotherapy with or without immunotherapy following nephroureterectomy for upper tract urothelial cancer.

Co-operated with the Medical Research Council on SORCEII trial3, a randomised controlled trial investigating the role of sorafenib as adjuvant therapy in RCC. Leadership Further advanced standard of care improvements with SURTIME124 that were incorporated into the European Association of Urology’s treatment guidelines.

1 Integrated iMMUnoprofiling of large adaptive CANcer patient cohorts

2 Chemotherapy with or without immunotherapy following nephro-ureterectomy for upper tract urothelial cancer (UTUC) (POUT2) - EORTC-1914-GUCG

3 A phase III randomised double-blind study comparing sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse (SORCE) - EORTC-30072-GUCG

4 Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma (SURTIME) - EORTC-30073-GUCG

Axel Bex Jose Pablo Maroto Jan Oldenburg Chair Secretary Treasurer

The Netherlands Cancer Institute- Hospital De La Santa Creu I Sant Pau, Akershus University Hospital, 8 621 56 Antoni Van Leeuwenhoekziekenhuis, Spain Norway trials members new members The Netherlands

26 27 GYNECOLOGICAL Top results

Completed accrual of a randomised trial on the effects of bevacizumab with or without CANCER GROUP acetylsalicylic acid and atezolizumab in patients with platinum resistant ovarian cancer1.

Completed accrual of a phase IB-II, open label, multicentre feasibility study of pazopanib in combination with Paclitaxel and Carboplatin in patients with platinum-refractory or resistant Mission ovarian, fallopian tube or peritoneal carcinoma2.

EORTC has successfully conducted clinical research in ovarian, cervical, uterine and vulvar cancer for Presented the first results of a randomised phase III study of neoadjuvant chemotherapy followed decades. Many of these trials were unique and changed clinical practice. Today, the Group is focused on by surgery compared to chemoradiation for stage Ib2-IIb cervical cancer, at the American Society molecular approaches to patient management. Their aim is to discover clinically-useful predictive factors of Clinical Oncology and the European Society of Gynaecological Oncology3. to identify subgroups of patients based on genomic patterns and activated pathways, and tailor clinical trials to them. The Group also stimulates clinical trials in rare cancers and underserved populations within Collaborated with the EORTC Quality of Life Group to construct questionnaires specific to ovarian, the gynecological field. cervix and endometrial cancer.4

Leadership Collaborated with the Gynecological Cancer InterGroup, including participation in international clinical trials and consensus opinion papers.

1 A phase II study of the anti-PD-L1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal adenocarcinoma - EORTC-1508-GCG

2 Phase IB-II, open label, multicentre feasibility study of Pazopanib in combination with Paclitaxel and Carboplatin in patients with platinum-refractory/ resistant ovarian, fallopian tube or peritoneal carcinoma - EORTC-55092-GCG

3 Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer - EORTC-55994-GCG

4 Stukan M, Zalewski K, Mardas M, et al. Independent psychometric validation of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). Eur J Cancer Care (Engl). 2018;27(1):10.1111/ecc.12639.)

Petronella Beatrix Ottevanger Fernanda Herrera Antonio Casado Herráez Treasurer Chair Secretary Radboud University Nijmegen Centre Hospitalier Universitaire Hospital Universitario San Carlos, 7 313 25 Medical Centre, The Netherlands Vaudois, Switzerland Spain trials members new members

28 29 HEAD AND NECK CANCER GROUP Mission

The Group’s research aims to contribute to better patient management at various stages of head and neck cancer by promoting and validating new treatments and examining individual responses to therapies. Oropharyngeal squamous cell carcinoma is a focus area along with locally advanced pharyngolaryngeal squamous cell carcinoma, pre-neoplastic lesions, salivary gland cancers, and recurrent and/or metastatic cancer. Top results Leadership Conducted the first of its kind interactive Group-wide brainstorm at the fall meeting to develop new trial concepts, innovative translational science projects and ‘out-of-the-box’ financing strategies.

Reached targeted recruitment goals for Best Of1, a ‘difficult-to-recruit’ trial randomising patients into trans-oral surgery. The trial involves studying ‘best of’ radiotherapy compared to the ‘best of’ surgery in patients with TI-T2, N0-NI oropharyngeal, supraglottic carcinoma and with TI, N0 hypopharyngeal carcinoma.

Actively recruiting for UPSTREAM2, a pilot study of personalised biomarker-based treatment Christian Simon Sjoukje Oosting strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the Chair Secretary head and neck. Centre Hospitalier Universitaire University Medical Center Groningen,

Vaudois, Switzerland The Netherlands Started a Early Career Investigator Programme that produces newsletters on hot topics in head and neck oncology as well as offering regular webinars. Members also write reviews of the latest research and share proposals.

1 Phase III study assessing the “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with TI-T2, N0-NI oropharyngeal, supraglottic carcinoma and with TI, N0 hypopharyngeal carcinoma - EORTC-1420-HNCG-ROG

2 A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (UPSTREAM) - EORTC-1559-HNCG

Guy Andry Paolo Bossi

Treasurer Early Career Investigator leader 9 365 37 Institut Jules Bordet, Belgium Universita Di Brescia - Azienda Ospedaliera trials members new members Spedali Civili di Brescia, Italy

30 31 IMAGING GROUP

Mission

The Imaging Group aims to establish and maintain the scientific and clinical value of advanced imaging. Members develop specific analytical, review and quality control procedures based on EORTC clinical trials. Medical imaging such as CT, MRI and PET scans are used to make a diagnosis or prognosis, select therapy, monitor responses to therapy and yield pharmacokinetic information about drugs.

Leadership

Top results

Submitted a Horizon 2020 proposal as a co-applicant to establish an imaging data repository for Marion Smits Christophe Deroose artificial intelligence (AI) in oncology (radiomics, big data and AI are a focus of the Group). Chair Vice Chair

Erasmus MC, The Netherlands U.Z. Leuven, Belgium Progressed the DREAM1 study on diffusion-weighted magnetic resonance imaging assessment of liver metastasis to improve surgical planning.

Became more multidisciplinary with expertise in radiology and nuclear medicine as well as computational image analysis and image guided therapy.

1 DREAM: Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning - EORTC-1527-GITCG-IG

Laure Fournier Lioe-fee de geus-oei Secretary Treasurer 1 233 30 Hôpital Européen Georges Pompidou, Leiden University Medical Centre, trials members new members France The Netherlands

32 33 LEUKEMIA GROUP

Mission

The Group is focused on improving outcomes for adult patients with leukemias or related hematologic malignancies. Members operate clinical trials, including large standard-practice changing phase III studies. They lead strong translational research programmes analysing epigenetic therapy in acute Top results myeloid leukemia or myelodysplastic syndrome. The Group also develops robust survivorship studies, taking advantage of the large number of patients already included in phase III research. Launched an innovative medicine initiative called ‘Big Data for Better Outcomes’. The programme facilitates the use of diverse data sources to deliver results that better reflect health outcomes of treatments.

Leadership Initiated HARMONY1, the Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in Hematology. This project will gather, integrate and analyse anonymous patient data from diverse sources as part of the Big Data for Better Outcomes programme.

Created the Survivorship Project to understand and to improve long-term outcomes for acute myeloid leukemia patients as part of the SPARTA trial2.

1 Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY (HARMONY) - RP-1655

2 The Survivorship Project to understAnd and to impRove long-Term outcomes for Acute myeloid leukemia patients (SPARTA) - RP-1479

Michael Lübbert Heiko Becker Laimonas Griskevicius

Chair Secretary Treasurer Universitaetsklinikum Freiburg, Universitaetsklinikum Freiburg, Vilnius University Hospital Santariskiu 3 172 6 Germany Germany Santaros Clinics Klinikos, Lithuania trials members new members

34 35 LUNG CANCER GROUP

Mission

This Group aims to challenge, re-define and develop standards of care for loco-regional as well as systemic treatments for lung cancer. This extends to mesothelioma and thymomas. Projects are designed to integrate disciplines such as imaging, translational research, quality of life and quality assurance. The Group is also focused on studying the use of immunotherapy to treat lung cancer.

Leadership

Top results

Brought together experts from medical societies to compile a consensus definition for synchronous oligo-metastatic non-small cell lung cancer, published in the Journal of Thoracic Oncology.1

Awarded the best recruiting study across all Groups for APPLE2 during the EORTC Group Annual Meeting (EGAM). The study involves research on the feasibility and activity of AZD9291 (osimertinib) Benjamin Besse Anne-Marie Dingemans Thierry Berghmans treatment on positive plasma T790M in EGFR mutant NSCLC patients. Chair Secretary Treasurer Institut Gustave Roussy, France Erasmus MC, The Netherlands Institut Jules Bordet, Belgium Funded a one-year statistician fellowship to analyse the MAGRIT3 database, building our future adjuvant trial and supporting more publications.

Early Career Investigators in the Group created a European network for future leaders in oncology research across different disciplines.

1 Dingemans A-M., Hendriks L., Berghmans T., et al. Definition of Synchronous Oligometastatic Non–Small Cell Lung Cancer—A Consensus Report. Journal of Thoracic Oncology. 2019; vol.14; issue 12; p. 2109-2119, doi: 10.1016/j.jtho.2019.07.025

2 APPLE trial:Feasibility and activity of AZD9291(osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients - EORTC-1613-LCG

3 MAGRIT is the study data received from GSK, known as EORTC 1733. Numerous research projects are planned for this data.

Matteo Giaj Levra Jessica Menis Early Career Investigator leader Early Career Investigator leader 8 475 50 Centre Hospitalo-Universitaire de Istituto Oncologico Veneto Padova, Italy trials members new members Grenoble, France

36 37 LYMPHOMA GROUP

Mission Top results

The Group is focused on Hodgkin Lymphoma (HL), a rare cancer. When treated correctly, HL can be cured, but Opened COBRA1, a phase II study for newly diagnosed patients with stage 3-4 HL, designed to test late toxicity (second cancers, cardiovascular diseases and fatigue) is a major concern. New trial initiatives aim treatment intensification (from BV+AVD to BrECADD) based on interim PET performed after one to reduce both acute and late toxicity, whilst maintaining high cure rates. Research assesses all aspects of the cycle of chemotherapy. disease to achieve a better basis for personalised treatment. Completed the final analysis of LYMG-ROG2, a phase III randomised study on low-dose total body irradiation and involved field radiotherapy in patients with localised stages I and II, low grade non- Leadership Hodgkin’s lymphoma.

Expanded the Group’s large database to a total of 6 657 long follow-up patients. The survivorship workstream is analysing the data with publications coming soon.

New members expanded the Group to previously unrepresented countries including Spain and Ireland.

1 Very early PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single – arm phase II study - EORTC-1537-LYMG

2 A Phase III randomized study on low-dose total body irradiation and involved field radiotherapy in patients with localized, stages I and II, low grade non- Hodgkin‘s lymphoma - EORTC-20971-22997-LYMG-ROG

Igor Aurer Wouter Plattel Elly Lugtenburg

Chair Secretary & Early Career Treasurer Investigator leader 9 273 30 University Hospital Centre Zagreb, University Medical Center Groningen, Erasmus MC, The Netherlands trials members new members Croatia The Netherlands

38 39 MELANOMA GROUP

Mission

The Group aims to improve the clinical care of patients suffering with cutaneous or ocular melanoma, and to increase knowledge about melanoma acquisition and progression. Group sub-committees focus on topics including epidemiology, early stage melanoma, surgery, pathology and systemic therapy Top results (adjuvant and for advanced disease). Published a study on the prognostic and predictive value of staging through the American Joint Leadership Committee on Cancer (AJCC) that showed consistent benefit related to adjuvant pembrolizumab.1

Published the long-term results from a double-blind phase III randomised trial, which showed a sustained survival benefit with adjuvant ipilimumab in patients with high risk stage III melanoma.2

Launched a study in advanced metastatic BRAF mutated melanoma patients. It examines a planned switch to immunotherapy after 12 weeks induction of targeted therapy with encorafenib and binimetinib versus immediate treatment with immunotherapy.3

Celebrated the 50th anniversary of the Group in Florence with a meeting in October 2019, including two memorial lectures dedicated to Christiane Voit and Martin Gore. Christiane Voit was a well- Alexander van Akkooi Paul Lorigan Ghanem Ghanem known pioneer for melanoma ultrasound diagnostics while Martin Gore was a leading melanoma Chair Secretary Treasurer immunotherapy pioneer. The Netherlands Cancer Institute - Antoni The University of Manchester and Institut Jules Bordet, Belgium

Van Leeuwenhoekziekenhuis, The Christie NHS Foundation Trust, Significantly grew the Early Career Investigator leader programme, receiving 26 abstracts for the The Netherlands United Kingdom Florence meeting from promising young researchers.

1 Adjuvant immunotherapy with anti-PD-I monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma - EORTC-1325-MG

2 Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma : A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group - EORTC-18071-MG

3 Combination of targeted therapy (Encorafenib and Binimetinib) followed by combination of immunotherapy (Ipilimumab and Nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation: an EORTC phase II randomized study (EBIN) - EORTC-1612-MG

Bastian Schilling Sara Valpione

Early Career Investigator leader Early Career Investigator leader 6 548 38 University Clinic Wurzburg, Germany The University of Manchester and The Christie trials members new members NHS Foundation Trust, United Kingdom

40 41 PATHOBIOLOGY GROUP

Mission

Pathobiology research at EORTC aims to identify and validate biomarkers across cancer types that can be used to develop new or more targeted treatments. The Pathobiology Group aims to actively contribute to clinical research within EORTC and to perform collaborative studies into biomarkers.

Leadership

Top results

Implemented a cross-group policy for biobanking with members contributing to the IMI IMMUCAN1 project, which involves a central processing laboratory for isolating PBMCs, genomic DNA and plasma for cfDNA.

Initiated a project with the Dutch Cancer Society on the role of APOBEC3B in breast cancer Paul Span Ira Skvortsova therapy resistance. Chair Secretary

Radboud University Medical Center Innsbruck Universitätsklinik, Austria Began a project with the Breast Cancer Research Foundation on RNA sequencing of male breast Nijmegen, The Netherlands cancers to identify predictors of prognosis and drug targets.

Hosted international meetings including ‘Brain Tumours: from Bench to Clinic’ related to new glioblastoma therapies in Ljubljana, Slovenia as well as ‘Cancer Metastasis’ in Tirol, Austria to build bridges between pre-clinical and clinical oncologists.

1 Integrated IMMUnoprofiling of large adaptive CANcer patients cohorts (IMMUcan) - RP-1828

Maurizio Callari Gert Van den Eynden Treasurer Early Career Investigator leader 101 13 2 Cruk Cambridge Institute, GasthuisZusters Antwerpen - Sint- members new members projects United Kingdom Augustinus , Belgium

42 43 PHARMACOLOGY & MOLECULAR MECHANISMS (PAMM)

Mission

This Group aims to stimulate preclinical and clinical research of anticancer drug effects and drug-related molecular pathology. PAMM is an integral part of the EORTC’s Translational Research Division, delivering information for projects with other disease-oriented groups, particularly in early-stage development. Top results

Welcomed more than 100 participants to the PAMM winter meeting in Verona in February 2019, Leadership bringing scientists and physicians together to share data and collaborate to improve drug development and translational research that can travel ‘from the lab to the bedside’.

Launched a very well-attended course in Verona on Preclinical and Early-phase Clinical Pharmacology with 82 participants, who were mostly young clinical fellows and PhDs from 8 different European countries.

Increased collaboration with EORTC Disease-Oriented Groups as demonstrated by numerous publications with EORTC clinicians.

Eric Raymond Elisa Giovannetti Annette Larsen

Chair Secretary Treasurer Groupe Hospitalier Paris Saint-Joseph, Vrije Universiteit University Medical Center, Université Pierre et Marie Curie, Hôpital 115 20 100 France The Netherlands Saint-Antoine, France members new members participants

44 45 QUALITY OF LIFE GROUP

Mission Top results This Group aims to better understand the effects of cancer and treatment on health-related quality of life for patients across diverse population groups and cultures. Launched EORTC Core Function Quality of Life Questionnaire, known as EORTC QLQ-F171, in over 100 languages. The QLQ-F17 enables users to measure the core functioning of cancer patients as Members develop and refine related questionnaires for oncology clinical trials, other well-designed assessed by EORTC QLQ-C30 together with disease-specific QLQ questionnaires, item lists (from research studies and clinical practice. They also collaborate with other EORTC research groups to the EORTC Item Library) and other measurement systems. implement studies in clinical trials. Expanded the use of the EORTC Item Library with 300 new users requesting access and 40 customised item lists created and implemented in 42 different studies.

Published thresholds2 to define clinical importance for the various domains of the EORTC QLQ-C30 to allow better interpretation of quality of life results in daily clinical practice and research.

Leadership Developed much-needed questionnaires to assess quality of life for patients with rare cancers.

Attracted over 300 experts and 30 world-class researchers to the 5th EORTC Quality of Life in Cancer Clinical Trials conference in May 2019.

1 Groenvold M, Aaronson NK, Bjordal K, Darlington AS, Kulis D, Piccinin C, Bottomley A Measuring function: Introducing the EORTC QLQ-F17 Core Function Questionnaire, abstract, ISOQOL 2019

2 Giesinger JM, Loth FLC, Aaronson NK, Arraras JI, Caocci G, Efficace F, Groenvold M, van Leeuwen M, Petersen MA, Ramage J, Tomaszewski KA, Young T, Holzner B; EORTC Quality of Life Group. Thresholds for clinical importance were established to improve interpretation of the EORTC QLQ-C30 in clinical practice and research., J Clin Epidemiol. 2020 Feb;118:1-8. doi: 10.1016/j.jclinepi.2019.10.003. Epub 2019 Oct 19

Anne-Sophie Darlington Karin Kuljanic Susanne Singer

Chair Secretary Treasurer School of Health Sciences, University of Klinicki Bolnicki Centar Rijeka, Croatia Johannes Gutenberg Universitätsklinikum 14 150 23 Southampton, United Kingdom - Mainz University Medical Center, Germany trials members new members

46 47 EORTC INFRASTRUCTURE PROJECTS “EORTC transcends across all disciplines”

48 49 E²-RADIatE

The E²-RADIatE platform gathers ‘real-world’ data on patients treated with radiation oncology in Europe.

SPECTA The platform represents a unique collaboration between the EORTC and the European Society Precision oncology is the future of cancer treatment and through for Radiotherapy and Oncology (ESTRO) to build the SPECTA platform, EORTC is helping to lead the way. The pan- collective knowledge on how treatments impact European platform allows for the rapid implementation of new patient survival and quality of life. clinical trials and robust translational cancer research. 2019 HIGHLIGHTS The molecular tumour boards emerging from SPECTA enable clinicians to make far more informed clinical decisions based on We opened OligoCare, the first cohort to the genomic ‘best fit’ profile of patients. launch on E²-RADIatE. Radical local treatment of metastases has rapidly expanded in recent SPECTA aligns research into a single protocol and patient years due to new insights into its biology and informed consent with one clinical database. With a centralised progression along with improved imaging and process, it ensures high-quality collection and storage of human new local radiation techniques. The platform’s biological material. broader and more blended approach to evidence generation allows for easier identification of AYA patterns and best practice. 2019 HIGHLIGHTS For adolescent and young adults in Belgium was the first country activated on the Three SPECTA downstream projects were collaboration with the German Cancer platform with OligoCare opening for enrolment developed and opened to recruitment. Each Research Center (DKFZ) on 25 June 2019 at Hôpital De Jolimont. project achieved considerable efficiencies Currently, a total of 17 sites are activated in compared to stand-alone clinical trials both Belgium, France, Italy, the Netherlands and in terms of planning with activation in less Arcagen Switzerland. than eight months, as well as cost with For patients with rare metastatic or locally 55 per cent estimated savings. advanced cancer with the European Network In 2020, OligoCare should activate a further 53 for Adult Rare Solid Cancers (EURACAN) sites in 14 countries including: Austria, the Czech Throughout the year, SPECTA added 36 new Republic, Germany, Norway, Poland, Portugal, investigators from 28 sites, bringing the Slovenia, Spain, Sweden and the United Kingdom. number of sites open to recruitment to 46 in IMMUcan With the current schedule, we expect 300 14 European countries with 63 authorised patients to enroll by March 2021. investigators. Today, the SPECTA platform covers IMMUcan on the interaction between 13 different tumour types with an ambitious tumours and the micro-environment in five plan for expansion. cancer types funded with an IMI grant

50 51 OUR PARTNERS

We partner with organisations that share our mission to improve survival and quality of life for patients with cancer. Partners lend their expertise with clearly defined responsibilities in our structure, while adhering to EORTC’s principles of independence and quality.

RESEARCH NE ICAL TWOR CLIN KS SURCARE INDUSTRY With SURCARE, we created a platform to improve the quality of surgery in cancer research and

S facilitate standardisation of surgical techniques R P E A K CD Y SP D A E F E and central monitoring of surgical outcomes. R M Y S C

C & I A

L EN H N TI T E O A S e T C P C S P P A E C The platform is a collaborative project with the

R s O R O I

European Society of Surgical Oncology (ESSO) and

the Japanese Clinical Oncology Group (JCOG).

2019 HIGHLIGHTS

S O

E S

G R

U O

LAT

completed began enrol- expan-

1409 CLIMB 1527 DREAM ESSO partnership

patient recruitment. The ling patients. It evaluates ded to surgeons across

study evaluates the surgical the accuracy of diffusion EORTC disease-oriented

and long-term outcomes weighted magnetic reso- groups. This collaboration of initially unresectable nance imaging in assessing is leading to the establish- colorectal liver metastases the sites of disappearing ment of surgical committees to establish thresholds metastasis among patients to assess new surgical pro- for quality of care within with complex colorectal liver posals and standardise Europe.The results of the metastases who respond to quality assurance tools. primary analysis will be systemic therapy and use “The EORTC serves as bridge between published in 2020. this imaging biomarker for the academic community and patients” precise surgical planning. Denis Lacombe, EORTC Director General

52 53 ENGAGING PATIENTS

As a patient-centered organisation, we seek to engage patients in far more than just clinical trials. We also include patients in the design of research itself, and work to share scientific information in plain language that is easy to understand and apply.

ENGAGING PATIENTS IN RESEARCH DESIGN

When designing clinical trials, we primarily work with two patient groups to review key materials including: the study synopsis, protocol and patient information sheet and informed consent.

Protocol Review Committee ensures the “As a patient I can share the knowl- relevance and high quality of research concepts edge, experiences and insight I with members including cancer specific have gained through being a cancer experts, methodologists and independent patient. My lived experiences of external patient experts. being on the receiving end of healthcare can help to shape how future Group of Patient Experts finds the right research is undertaken, and in the balance between completeness of the patient longer-term help shape and improve information, document length and language. how care is provided.”

Both groups have approximately 150 members amongst whom relevant reviewers are selected Patricia F. to contribute to each EORTC project. EORTC Patient Panel member

54 55 SHARING THE ‘LIVED EXPERIENCE’ OF CANCER

The EORTC Patient Panel shares the ‘lived experience’ of cancer with the EORTC community. The eight member panel includes independent patient advocates, former patients and caregivers. The panel is not cancer-specific and is purposely FACING THE CHALLENGES AHEAD diverse in terms of nationality, age, gender and life experience. While we make progress towards these goals, we are working to overcome some key challenges. Every two years, we host Patient Days to raise We are confident that we have the talent and awareness about opportunities for patients to resolve to address each one. engage with the EORTC and to provide training opportunities for patient experts. So far, we have Selection. Where to find patient experts and hosted four editions of Patient Days, each with how to select the most suitable profiles? This 150 patient experts from over 60 organisations. requires striking the right balance between highly trained patient experts and truly lay patients.

Diversity. How to ensure diverse patients are represented from across Europe? Many patient PLANS FOR THE FUTURE voices come from the United Kingdom, the We have ambitious plans to engage more patients Netherlands and Belgium. We have found it more and enhance their experience with the EORTC, difficult to find representatives from Southern, including: Northern and Eastern Europe.

Increasing EORTC’s visibility with patients, Sustainability. How to maintain our trusted especially by making the website more relationships with current patient experts and patient centered. engage new ones? Since the majority are cancer patients or survivors, health problems can Creating a practical tool-kit to support patient prevent them from sustained participation. involvement in all disease oriented groups. Rewards. How to reward patients for their par- Continuing to improve the readability of lay ticipation and ensure a satisfactory experience? summaries of trial results. At present, means to reward patient experts is limited. Creative solutions are required to meet Illustrating in publications and other forums this need. that patient engagement is a ‘must have, not nice-to-have’. Scalability. How can we feasibly scale-up patient engagement? EORTC has an ambitious research Developing training to share knowledge and agenda and a limited number of patient experts trial information with patients. at present, making scale a challenge to achieve.

56 57 FELLOWSHIPS EVENTS & In 1991, we established the EORTC Fellowship While we are grateful to all our supporters Programme to encourage physicians, statisticians worldwide, we are especially appreciative of the and scientists from around the world to engage in contributions from Belgian-based organisations. CAMPAIGNS European clinical cancer research. This includes Kom Op tegen Kanker (Stand Up QUALITY OF LIFE IN CANCER CLINICAL Against Cancer) for their support to the Emmanuel TRIALS CONFERENCE Selected fellows work for up to three years at van der Schueren fellowship, and the European 16 - 17 May / Brussels, Belgium EORTC headquarters in Brussels, the capital Society for Paediatric Oncology (SIOPE) and of Europe. It is a unique opportunity to absorb Fonds Cancer (FOCA) for their continued support The EORTC Quality of Life in Cancer Clinical all aspects of creating, activating and bringing of the medical doctors fellowship. Trials Conference focused on the state of quality cancer clinical research projects to maturity, from of life and other patient-reported outcomes the inside. (PROs) research. We welcomed over 200 diverse “What l like the most about the participants including researchers, regulators, Fellows are exposed to a range of training to fellowship is how people respect industry leaders, healthcare professionals, reinforce and expand their knowledge of clinical and take care of each other”. patients and their advocates. research. It is also a chance to use EORTC’s rich databases to work on practice-changing Abigirl Machingura, Statistician Fellow (Zimbabwe) The conference showed that PROs are publications. becoming more accepted and major efforts are ongoing internationally to standardise PROs measurement, analysis and reporting in trials. 29 years of Awarded Regulators are keen to ensure that the right achievement 10 Fellowships questions are asked, and the right answers are communicated. Improved technology and in 2019* flexibility of measurement instruments are also sponsored 192 fellows 5 statisticians making PROs data more robust. Patients are welcomed 40 nationalities 4 medical doctors increasingly becoming patient partners in a 1 researcher growing global community.

* Fellows who started in 2019

Welcomed the world

to the EORTC “EORTC drives innovation by education EUROPE: Belgium, Germany & The Netherlands and scientific dissemination through its AFRICA: Cameroon, Ghana & Zimbabwe conferences and courses. Bringing all ASIA: Australia & Japan stakeholders together to discuss the latest LATIN AMERICA: Brazil data in cancer, it endeavours to improve the standard of care for patients”

58 59 ONE-DAY METHODS IN CLINICAL CANCER 20 September / Brussels, Belgium RESEARCH WORKSHOP 15 - 21 June / Zeist, The Netherlands The One-Day takes participants on a journey through the strategies and principles for The Methods in Clinical Cancer Research collaboration with the EORTC. Participants Workshop is a week-long course designed to discover all that is involved in our clinical trials and educate and train Early Career Investigators in other research activities, from pre-development the best practices of clinical trial design. It through to publication. provides access to experienced clinical investigators from diverse institutions with The goal: to realise the full potential of the EORTC expertise across all areas of clinical research. In 2019, over 40 world-renowned faculty network to produce practice-changing research members taught 80 students from 17 diverse that improves patient survival and quality of life. The workshop is organised in collaboration with countries who were selected in a competitive In 2020, we intend to make the One-Day a virtual the European Society of Medical Oncology (ESMO) application process. The majority of participants event to further expand its reach and impact. and the American Association for Cancer Research were medical oncologists, followed by paediatric (AACR). Together we have provided training to and clinical oncologists. Protocols ranged from over 1 600 investigators from around the world phase I to phase III with a majority in phase II since 1999. trials for 29 different tumour types. Campaigns in 2019

WORLD CANCER DAY 4 February

CLINICAL TRIAL STATISTICS FOR ‘I am and I will’ was the theme of World Cancer NON STATISTICIANS Day that we celebrated with a social media 11 - 14 June / Brussels, Belgium campaign that achieved more than 11 000 views in 2019. The short videos we shared put Taught by the EORTC’s world-class biostatisticians, the spotlight on the vital role of EORTC staff in this course provides an introduction to the cancer research that improves patient survival statistical methods used for the design, conduct and quality of life. and analysis of cancer clinical trials. Participants gain a deep understanding of the statistical World Cancer Day has been raising awareness principles whilst avoiding overly technical of cancer and encouraging governments and formulations. They also become better equipped people worldwide to take action since 2000. The to design their own clinical research, work in a Day is led by the Union for International Cancer multidisciplinary team involving statisticians Control to support the goals of the World Cancer and critically appraise the scientific value of Declaration, written in 2008. published research.

The support we received from our partner In 2019, over 70 participants enrolled in the course organisations, patients and their advocates and with over 40 per cent from academia and 15 per the EORTC network was decisive to the campaign’s cent from industry. The remaining students were success. A special thanks to all who participated. from not-for-profit organisations and the EORTC.

60 61 BREAST CANCER AWARENESS MONTH October

EORTC staff were decked out in pink on October 18 to show their support and raise awareness about breast cancer, by far the most common cancer in women worldwide. Throughout the month we hosted events to increase attention and support for the awareness, early detection and treatment as well as palliative care of this disease.

One highlight from the month was ‘Breast cancer: what do I need to know’, an event we organised in collaboration with the Belgian NGO, Breast International Group (BIG). Well-known breast cancer specialists including Prof. Martine Piccart, Dr. Michial Ignatiadis and Dr. Peter Vuylsteke shared about clinical trials in breast cancer underway and future trends in research. Breast cancer survivors who are also medical doctors shared their unique perspectives on the latest treatments as well.

MOVEMBER November EORTC GENERAL Movember is an annual event that challenges men to grow moustaches during the month of November ASSEMBLY, BOARD to raise awareness about major health issues facing men: prostate cancer, testicular cancer and men’s AND COMMITTEES suicide. Proceeds from this month-wide event go towards innovative research and projects that The General Assembly is EORTC’s legislative body, where members benefit men’s health around the world. discuss and approve policies, proposals and strategies. The General Assembly delegates specific functions to the Board, EORTC staff grew hairy moustaches of their own to Committees and Appointees. The EORTC Board is EORTC’s steering support the cause and also trekked across a total of and executive body, advising the General Assembly on new 1 300 kilometers in a Movember fitness challenge. activities and formulating proposals for ratification. Several EORTC Nearly 1 200€ in donations were generated Committees oversee EORTC’s strategy and ensure the scientific throughout the month from EORTC staff to benefit relevance, value, quality and independence of our research. the Movember Foundation.

62 63 FINANCIALS INCOME 2019 € 41.8 M 11% Restricted & Unrestricted Grants TOTAL REVENUE IN THE 2019 FISCAL YEAR:

Consolidated figures (EORTC, ECRF, FRIENDS OF EORTC, FFRTC) € 41.8 M 12% Royalties

WE RAISED 5% Subsidles

1% Events € 39.1 M for clinical cancer research € 2.7 M for operating expenses 1% Financials & Others WE INVESTED 9% Grants Industry (Regulatory Trials) € 35.7 M in clinical cancer research 61% Grants Industry (Investigators initiated Trials) € 0.6 M in education / fellowships € 1.3 M in development, communication & professional events EXPENDITURE 2019 € 4.3 M in operating expenses (taxes, administration, HQ) 7% Administration € 41.9 M 3% Communication & events NET ASSETS 2% Office

€ 70.4 M in 2019 1% Fellowship, Training, Education € 69.5 M in 2018 1% Financials & Taxes 1% Devlopment

85% Research Projects

64 65 ECRF EORTC Cancer Research Fund

THE EORTC CANCER RESEARCH FUND (ECRF)

66 67 ECRF ECRF EORTC Cancer Research Fund EORTC Cancer Research Fund

About us

The EORTC Cancer Research Fund (ECRF) is an By keeping administrative costs low, 96 per cent Total restricted & independent non-profit association founded in of donations to ECRF directly fund practice- unrestricted funds 1976 under the honorary presidency of Prince changing academic clinical research and the Philip, the Duke of Edinburgh. ECRF’s mission education of the next generation of oncologists raised in 2019 is to promote, encourage and support research and cancer researchers. on the treatment of cancer under the auspices Consolidated figures (EORTC, ECRF, of the EORTC. Since 2014, ECRF has been privileged to count Prince Albert II of Monaco as its Honorary FRIENDS OF EORTC, Fondation Over the past 43 years, the ECRF has raised President and Count Diego du Monceau de Francaise RTC 1) millions of euros to fund EORTC trials and Bergendal as the Chairman of the Fund. projects to develop new treatments and care that have increased survival and quality of life for cancer patients. “Partnering with EORTC means saving more lives €4.4M RESTRICTED GRANTS The grants and donations that power our work and shaping the future of come from a diverse range of supporters, from cancer therapy.” institutions and foundations to the private sector and generous individuals across Europe Count Diego du Monceau de Bergendal and around the world. Chairman of the fund €657K UNRESTRICTED GRANTS Our Board

ECRF TRUSTEES ECRF ADVISORY BOARD

Alejandra MacCrohon-Gardner SP Alexandre Eggermont (Prof) FR NUMBER OF ACADEMIC PROJECTS 2 Denis Lacombe BE Cigdem Simavi TU 78 Diego du Monceau BE Daisy Pictet-Althann CH FUNDED (PARTIALLY & IN FULL) Edward Chandler UK John Smyth (Prof) UK Evelyne Genta UK Jean Claude Horiot (Prof) CH Gordon McVie UK Lady Solti UK Guy Beniada FR Oscar Lewisohn UK NUMBER OF Jean de Gunzburg UK Robert Waley Cohen UK 18 3 Jean-Leopold Schuybroek BE Susanne Schroder UK FELLOWSHIPS SPONSORED Marc Leland UK Prince Guillaume of Luxembourg LUX Roger Stupp US 1 Friends of EORTC & Fondation Francaise RTC are registered Sally Lo HK charities in the UK and France respectively Suzan Sabanci-Dincer TUR 2 No industry involvement Victoria Agnew UK 3 Total number of fellows at the EORTC in 2019

68 69 ECRF EORTC Cancer Research Fund

Highlights 2019

RAISING €1.2 MILLION IN ONE EVENING GALA

Together with the Walgreens Boots Alliance (WBA), Prince Albert of Monaco hosted a gala fun- draiser that generated €1.2 million to support two ground-breaking EORTC initiatives.

The first involves critical investments in SPECTA, a project advancing the molecular understanding of cancer to selectively target specific patient profiles with ‘best fit’ treatments.

The second beneficiary was the STRASS II research project, targeting high-risk retroperitoneal sarcoma which is an aggressive and rare cancer affecting soft tissues.

STRASS II is the first official trial on the potential benefits of chemotherapy before surgery to improve disease control and survival in patients with high-risk retroperitoneal sarcoma.

During the gala, over 200 guests at the Hotel de REALISING THE POTENTIAL OF PRECISION ONCOLOGY WITH WBA Paris enjoyed a 1960s themed evening with a live auction of five unique items generously donated Precision oncology is the future of cancer ‘best fit’ profile of patients. In recognition of for the cause. The gala concluded with a per- treatment and with the Walgreens Boots Alliance, SPECTA’s achievements and future potential, formance by London’s West End star, Katherine we have made exciting leaps forward through the WBA made an additional commitment of Kingsley. SPECTA platform. €5 million in 2019.

EORTC would like to thank Prince Albert, Ambas- The pan-European platform allows for the rapid This gift enables us to expand research to all types sador Evelyne Genta of Monaco and Ms Ornella implementation of new clinical trials and robust of cancer, including rare young adolescent cancers. Barra of Walgreens Boots Alliance for their con- translational cancer research. tinued support. By the end of 2020, the SPECTA platform is The molecular tumour boards emerging from expected to work with 254 doctors in more than SPECTA enable clinicians to make far more 180 hospitals in 21 European countries. informed clinical decisions based on the genomic

70 71 ECRF ECRF EORTC Cancer Research Fund EORTC Cancer Research Fund

Purpose-driven and employee-led fundraising

From family fun days to ugly holiday sweater contests, employees across Walgreens Boots Alliance have participated in all sorts of fundraising activities to benefit the EORTC The partnership with EORTC is far more than and SPECTA. In 2019, employees launched the a check-writing exercise for Walgreens Boots Alliance Healthcare Games to raise funds through Alliance. It is an opportunity for employees to sport, cooking contests and live auctions. put WBA’s corporate purpose - to help people live healthier and happier lives - into action. Walgreens Boots Alliance embodies the kind And it is an opportunity they have embraced of purpose-led fundraising that engages with a spirit of creativity and resolve that we employees that we encourage amongst all our want to acknowledge and celebrate. corporate supporters.

Launching a new transatlantic partnership The EORTC Cancer Research Fund made new the treatment of oligometastatic disease in lung, investments in 2019 in the E²-RADIatE platform, breast, prostate and colorectal cancer. In 2019, a new charitable partnership was ‘EORTC has long recognised that to advance an initiative that is gathering ‘real-world’ data launched to unite transatlantic organisations in treatment and quality of life for cancer on patients treated with radiation oncology Led by Dr. Yolande Lievens and Dr Pïet Ost of the fight against cancer: the Collaboration for patients across tumour types and countries, in Europe. Universitair Ziekenhuis Gent, researchers are Cancer Prevention, Research and Support. we must collectively work with like-minded seeking to identify the factors impacting overall Members include the EORTC, Walgreens Boots organisations to deliver results for patients’, The platform represents a unique collaboration survival including the cancer, organ affected, Alliance, Macmillan Cancer Support, Susan said EORTC’s Director General Dr. Lacombe. between the EORTC and the European Society for staging and treatment. G. Komen® Foundation and the Leukaemia ‘This collaboration marks the first steps towards Radiotherapy and Oncology to build collective Lymphoma Society. a holistic and dynamic approach in the fight knowledge on how treatments impact patient against cancer’. survival and quality of life. Together, we are collaborating on initiatives to develop and support innovative cancer research In 2019, OligoCare1 became the first project infrastructure and share best practices that hosted on the E²-RADIatE platform to include improve patient care. its first patient. The project is collecting data on

72 73 ECRF ECRF EORTC Cancer Research Fund EORTC Cancer Research Fund

INVESTING IN THE NEXT GENERATION OF ONCOLOGY PROFESSIONALS WE NEED PARTNERS

Since 1991, the ECRF supports EORTC’s Fellowship Paediatric Oncology, Fondation Contre le Cancer, LIKE YOU programme which enables physicians, University of Leiden, Japan Clinical Oncology statisticians and scientists from around the Group and Innoviris. Improving cancer survival requires independent world to engage in world-class research for up world-class research that leads to breakthrough to three years at EORTC headquarters in Brussels. Belgian American Education Foundation (BAEF) clinical trials. The EORTC is uniquely positioned An ongoing partnership between the ECRF and the to deliver on this mission as the strongest cancer- In 2019, the number of fellowships has reached BAEF, provide scholarships that enable American fighting organisation in Europe. a total of 18 fellows*. The programme benefits scientific students to spend a year at the EORTC from the longstanding support of organisations in Brussels. We operate on a scale that would be impossible including: Fonds Cancer, European Society for *Total number of fellows at the EORTC in 2019 to undertake at a national level with a record of achievement dating back to 1962.

WELCOMING A NEW ECRF TRUSTEE “EORTC is the strongest independent No tumour is too rare to tackle at the EORTC. Our non-profit cancer-fighting body in research is solution-driven for all types of cancers, Mrs Alejandra Mac-Crohon Gardner, wife of the Europe, and supporting it means joining regardless of their commercial value. former US Ambassador to the European Union, the fight against cancer. I’m proud to became the newest addition to the ECRF Board join the Board to advance its mission” We leave no-one behind because ultimately, cancer of Trustees in 2019. touches us all. If not directly, through our families, Alejandra Mac-Crohon Gardner, ECRF Trustee friends and our countries’ healthcare budgets. “Clinical trials are the most We need your help to power our progress forward, important step on the journey and welcome you to join us on this journey. Together, we can increase patient survival and from laboratory to practice quality of life. changing medical treatments.”

We make it easy for businesses and individuals to support our mission. Take the first step and reach out to our team to start a conversation today! ECRF Board of Trustees (during the November 2019 Board Meeting in Brussels) from left to right: HRH Prince Guillaume of Luxembourg, Mrs Alejandra Mac-Crohon Gardner, Dr John Smyth, Count [email protected] Diego du Monceau ECRF Chairman, Mrs Victoria Agnew, Mr Oscar Lewisohn +32 2 774 15 26

74 75 ECRF EORTC Cancer Research Fund

THANK YOU

EORTC and ECRF are grateful to all our supporters worldwide, including many private individuals who power our progress in the fight against cancer. On behalf of all cancer patients and their families, thank you.

Fonds Cancer (FOCA)

Details to make a donation

Belgium UK France PUBLICATIONS & EORTC ECRF Friends of EORTC Fondation Française RTC IBAN: IBAN: IBAN: BE79 0682 4292 7433 (EUR) GB30 COUT 1800 0201 FR76 3000 4009 3200 0100 CLINICAL TRIALS 2019 8843 95 (GBP) 3025 923 (EUR)

Rest of Europe & USA for EORTC Cancer Research Fund Transnational Giving Europe (TGE) King Baudoin Foundation US

76 77 OVERVIEW PUBLICATIONS 2019

65 Publications including 11 HQ

BY TUMOUR

Brain - 10 TOP 10 Breast - 2 Cancer in Elderly - 1 JOURNALS WHERE EORTC HQ - 11 WE PUBLISHED THIS YEAR Gastro Intestinal - 2 Head & Neck - 2 1 The New England Journal of Medicine Children’s Leukemia - 2 Leukemia - 2 2 The Lancet Oncology Lung - 7 Melanoma - 4 3 The Lancet Haematology Soft tissue & bone sarcoma - 4 4 Journal of Clinical Oncology

5 Annals of Oncology

European Journal of Cancer BY CROSS-DISCIPLINE 6

7 Clinical Cancer Research Imaging - 1 Infectious Disease - 1 8 Radiotherapy and Oncology Quality of Life - 12 Radiation oncology - 4 9 Neuro-oncology

10 Journal of the National Cancer Institute

78 79 PUBLICATIONS 2019

EORTC Groups Title Authors Journal DOI EORTC Groups Title Authors Journal DOI Brain Tumours Repeatability and reproducibility of Smits M, Bendzus M, Collette S, European https://doi. Brain Tumours The RANO Leptomeningeal Metastasis Le Rhun E, Devos P, Boulanger Neuro-Oncol- https://academic. relative cerebral blood volume measure- Jacobi-Postma L, Dhermain F, Journal of org/10.1016/j. Group proposal to assess response to T, Smits M, Brandsma D, Ruda R, ogy oup.com/neuro- ment in recurrent glioma Hagenbeek R, Clement P, Liu Y, Cancer ejca.2019.03.007 treatment: lack of feasibility and clinical Furtner J, Hempel JM, Postma oncology/academ- Wick W, van den Bent M, Heiland utility and a revised proposal. T, Roth P, Snijders T, Winkler F, ic/21/5/648/5306141 S. Winklhofer S, Castellano A, Hat- tingern E, Capellades J, Gorlia T, Brain Tumours Defining EGFR amplification status for French P, Eoli M, Sepulveda JM, Neuro-Oncol- https://doi. van den Bent M, Wen P, Bendszus clinical trial inclusion de Heer I, Kros JM, Walenkamp A, ogy org/10.1093/neuonc/ M, Weller M. Frenel JS, Franceschi E, Clement noz096 P, Weller M, Ansell P, Looman J Breast Cancer Molecular apocrine-like tumours in Bonnefoi H, MacGrogan G, British Journal https://doi. , Bain E, Morfouace M, Gorlia T, EORTC 10994/BIG 1-00 phase III study: Poncet C, Iggo R, Pommeret F, of Cancer org/10.1038/s41416- van den Bent M pathological response after neoadjuvant Grellety T, Larsimont D, Bécette 019-0420-y chemotherapy and clinical outcomes. V, Kerdraon O, Bibeau F, Ghnassia Brain Tumours INTELLANCE 2/EORTC 1410 randomized van den Bent M, Eoli M, Sepul- Neuro-Oncol- https://doi. JP, Picquenot JM, Thomas J, Tille phase II study of Depatux-M alone and veda JM, Smits M, Walenkamp A, ogy org/10.1093/neuonc/ JC, Slaets L, Bodmer A, Bergh J, with temozolomide vs temozolomide or Frenel JS, Francesschi E, Clement noz222 Cameron D. lomustine in recurrent EGFRamplified P, Chinot O, De Vos F, Whenham glioblastoma N, Sanghera P, Weller M, Dubbink Breast Cancer Reference Values for the EORTC QLQ-C30 Mierzynska J, Taye M, Pe M, European https://doi. H, French P, Looman J , Krause S, in Early and Metastatic Breast Cancer. Coens C, Martinelli F, Pogoda Journal of org/10.1016/j. Dey J, Ansell P, Nuyens S, Spruyt K, Velikova G, Bjelic-Radisic V., Cancer ejca.2019.10.031 M, Brilhante J, Coens C., Gorlia T, Cardoso F, Brain E, Ignatiadis Golfinopoulos V. M, Piccart M., Rutgers E, Van Brain Tumours Molecular evolution of IDH-wildtype Draaisma K, Chatzipli A, Taphoo- Journal of https://doi. Tienhoven G., Mansel R, Wildiers glioblastomas treated with standard of rn M, Kerkhof M, Weyerbrock A, Clinical Oncol- org/10.1200/ H., Bottomley A. care affects survival and design of preci- Sanson M, Hoeben A, Lukacova S, ogy jco.19.00367 sion medicine trials: a report from the Lombardi G, Leenstra S, Hanse M, Cancer in El- Cancer events in Belgian nursing home Wildiers H, Elseviers M, Mauer M, Journal of https://doi. EORTC 1542 study Fleischeuer, Leenstra S, Watts C, derly Task Force residents: An EORTC prospective cohort De Wolf J, Bastiaens E, Hatse S, Geriatric org/10.1016/j. McAbee, Angelopoulos N, Gorlia study. Hamaker M, Buntinx F, Dele- Oncology jgo.2019.03.005 T, Golfinopoulos V, Kros JM, Ver- peleire J, Uytterschaut G, Tryfoni- haak R, Bours V, van den Bent M, dis K, Janssen-Heijnen M. McDermott U, Robe P, French P. Children Leu- Long-term outcome evaluation of me- Piette C., Suciu S., Bertrand Y., British Journal http://doi. Brain Tumours Imaging necrosis during treatment is Nowosielski M, Gorlia T, Brom- Neurology https://doi. kemia dium/high risk acute lymphoblastic leu- Uyttebroeck A., Vandecruys E., of Haemathol- org/10.1111/ associated with worse survival in EORTC berg J, Sahm F, Harting I, Kick- org/10.1200/ kemia children treated with or without Plat G., Paillard C., Pluchart C., ogy bjh.16337 26101 study. ingereder P, Brandes A, Taphoorn jco.19.00367 cranial radiotherapy in the EORTC 58832 Sirvent N., Maurus R., Poirée M., M, Taal W, Domont J, Idbaih A, randomized study. Simon P., Ferster A., Hoyoux C., Campone M, Clement P, Weller M, Mazingue F., Paulus R., Freycon Fabbro M, Le Rhun E, Platten M, Claire, Thomas C., Philippet Golfinopoulos V, van den Bent M, P., Gilotay C., Van Der Werff J., Bendszus M, Wick W. Rohrlich P., Benoit Y.

Brain Tumours Temporal muscle thickness is an inde- Furtner J, Genbrugge E., Gorlia T, Neuro-Oncol- https://doi. Children’s Leu- Results of successive EORTC-CLG 58 Hofmans M, Suciu S, Ferster A., British Journal https://doi. pendent prognostic marker in patients Bendszus M, Nowosielski M, Gol- ogy org/10.1093/neuonc/ kemia 881 and 58 951 trials in paediatric T-cell Van Vlierberghe P, Mazingue F., of Haemathol- org/10.1111/ with progressive glioblastoma: trans- finopoulos V, Weller M, van den noz131 acute lymphoblastic leukaemia (ALL). Sirvent N, Costa V, Yakouben ogy bjh.15983 lational imaging analysis of the EORTC Bent M, Wick W, Preusser M. K, Paillard C, Uyttebroeck A., 26101 trial. Plantaz D, Plat G, Simon P, Millot F, Poirée M., Van Der Werff J., Brain Tumours Use of metformin and outcome of Seliger C, Genbrugge E, Gorlia International https://doi. Piette C, Minckes O, Rohrlich P., patients with newly diagnosed glioblas- T, Chinot O, Stupp R, Nabors B, Journal of org/10.1002/ijc.32337 Girard S, Cave H, Bertrand Y, De toma: Pooled analysis. Weller M, Hau P. Cancer Moerloose Brain Tumours Automated quantitative tumour Kickingereder P, Isensee F, Tursu- The Lancet https://doi. response assessment of MRI in neuro- nova I, Petersen J, Neuberger U, Oncology org/10.1016/S1470- EORTC Head- RECIST1.1 criteria for response evalua- Litiere S, Isaac G, de Vries E, Bo- Journal of https://doi. oncology with artificial neural networks: Bonkamp S, Brugnara G, Schell 2045(19)30098-1 quarters (for- tion not only applies to chemotherapy gaerts J, Chen A, Dancey J, Ford Clinical Oncol- org/10.1200/ a multicentre, retrospective study. M, Kessler T, Follyn M, Harting I, merly Central treated patients but also to targeted can- R, Gwyther S, Hoekstra O, Huang ogy JCO.18.01100 Sahm F, Prager M, Nowosielski M, Office - Data cer agents: a pooled database analysis . E, Lin N, Liu Y, Mandrekar S, Wick A, Nolden M, Radbruck A, Center) Schwartz L, Shankar L, Therasse Debus J, Schlemmer M, Heiland P, Seymour L. S, Platten M, von Deimling A., van den Bent M, Gorlia T, Wick W, EORTC Head- Sample size computation in phase II de- Neven A, Mauer M, Hasan B, Journal of Bio- https://doi.org/10.10 Bendszus M, Maier-Hein KH. quarters (for- signs combining the A’Hern design and Sylvester R, Collette L. pharmaceuti- 80/10543406.2019.1 merly Central the Sargent and Goldberg design. cal Statistics 641817 Brain Tumours MGMT Promoter Methylation Cutoff with Hegi M, Genbrugge E, Gorlia T, Clinical Cancer https://clincancerres. Office - Data Safety Margin for Selecting Glioblastoma Stupp R, Gilbert M, Chinot O, Research aacrjournals.org/ Center) Patients into Trials Omitting Temozolomide: Nabors B, Jones G, Van Criekinge content/25/6/1809 A Pooled Analysis of Four Clinical Trials. W, Straub J, Weller M.

80 81 EORTC Groups Title Authors Journal DOI EORTC Groups Title Authors Journal DOI EORTC Head- Radiotherapy practice for paediatric de Rojas T., Clementel E., Giralt European https://doi. Gastrointestinal Building a collaboration to improve Caballero C., Burock S, Alvarez L, European https://doi. quarters (for- brain tumours accross Europe and qual- J., Cruz O. , Boterberg T., Kort- Journal of org/10.1016/j. Tract Cancer surgical research through EORTC/ESSO Nilsson H., Ruers T, Senellart P, Journal of org/10.1016/j. merly Central ity assurance initiatives: Current situ- mann R.D., Gaze M., Moreno L., Cancer ejca.2019.03.018 1409-CLIMB Study : a propective liver Rivoire M, Stattner S, Primavesi Surgical Oncol- ejso.2019.05.028 Office - Data ation, international survey and future Janssens G. metastasis database with an integrated F, Troisi R, Gruenberger T, Heil ogy Center) perspectives. Quality Assurance program. J, Schnitzbauer A, Rahbari NN, Swijnenburg, Malik H, Protic M, EORTC Head- Improving the quality of care in the mo- de Rojas T., Puertas M., Bautista Clinical and https://doi. Kataoka K, Mauer M, Ducreux M, quarters (for- lecular era for children and adolescents F., de Prada I., Lopez-Pino, Rivero Translational org/10.1007/s12094- Poston G, Evrard S. merly Central with medulloblastom. B., Gonzalez-San Segundo C., Las- Oncology 019-02101-2 Office - Data saletta C., Madero L., Moreno L. Gastrointestinal Multidisciplinary management of stage Wagner A.D., Lordick F., Grabsch European https://doi. Center) Tract Cancer II-III gastric and gastro-oesophageal H, Terashima M, Terada M, Journal of org/10.1016/j. junction cancer. Yoshikawa T, Boku N, Kataoka K, Cancer ejca.2019.09.006 Smyth E, Mauer M, Haustermans EORTC Head- Cumulative toxicity in targeted thera- Altzerinakou MA , Collette L., Journal of the https://doi. K, Moehler M. quarters (for- pies: what to expect at the recommend- Paoletti X. National Can- org/10.1093/jnci/ merly Central ed Phase II dose. cer Institute djz024 Office - Data Head and Neck The statistical evalutation of treatment Fortpied C, Vinches M. Frontiers in http://doi. Center) Cancer and outcomes in Head and Neck Squa- Oncology org/10.3389/ mous Cell Carcimona Clinical Trials. fonc.2019.00634 EORTC Head- La randomisation adaptative bayési- Neven A, Gorlia T, Litiere S, Col- Innovations doi: 10.1684/ quarters (for- enne. lette L. et Thérapeu- ito.2019.0143 Head and Neck Organ Preservation and Late Functional Stelmes JJ, Gregoire V, Vander Frontiers in https://doi. merly Central tiques en Cancer Outcome in Oropharyngeal Carcinoma: Poorten V, Golusinski W, Szewc- Oncology org/10.3389/ Office - Data Oncologie Rationale of EORTC 1420, the “Best of” zyk M, Jones T, Ansarin M, Broglie fonc.2019.00999 Center) trial. D, Giger R, Klussmann, Evans M, Bourhis J, Leemans R, Spriano EORTC Head- Addressing the dichotomy between Salgado R, Solit D, Rimm D, European https://doi. G, Dietz A, Hunter K, zimmer- quarters (for- individual and societal approaches to Bogaerts J., Canetta R, Lively Journal of org/10.1016/j. mann F, Tinhofer I, Patterson J, merly Central personalized medicine in oncology. T, Span P, Bateman-House A, Cancer ejca.2019.03.025 Quaglini S, Govaerts AS, Fortpied Office - Data Makady A, Bergmann L, Nagai S, C, Simon C. Center) Smith C, Robson M, Savage M, Imaging Group Evaluation of diffusion-weighted MRI Carlin D, Weller A, Kramer G, Liu British Journal https://doi. Voest E, Sweeney C, Lambin P, and (18F) fluorothymidine-PET biomark- Y, Waterton J, Chiti A, Sollini M, of Radiololy org/10.1259/ Thomas M, Harris L, Lacombe D, ers for early response assessment in de Langen J, O’Brien M, Urbano- bjro.20190029 Massard C. patients with operable non-small cell wicz M, Jacobs B, deSouza N. lung cancer treated with neoadjuvant EORTC Head- Study risk assessment of Japan Clinical Miyamoto K, Nakamura K., Japanese https://doi. chemotherapy. quarters (for- Oncology Group (JCOG) clinical trials Mizusawa J, De Balincourt C, Journal of org/10.1093/jjco/ merly Central using the European Organisation for Re- Fukuda H. Clinical Oncol- hyz050 Office - Data search and Treatment of Cancer (EORTC) ogy Infectious Revision and Update of the Consensus Donnelly P, Chen S, Kauffman C, Clinical Infec- https://doi. Center) study risk calculator. Diseases Group Definitions of Invasive Fungal Disease Steinbach W, Baddley J, Verweij P, tious Diseases org/10.1093/cid/ - IDG (merge of From the European Organization for Clancy C, Wingard J, Lockhart S, ciz1008 IATG and IFIG) Research and Treatment of Cancer and Groll A, Sorrell T, Bassetti M, Akan EORTC Head- SPECTA-AYA: A unique molecular profil- de Rojas T, Kasper B, van der International https://doi. the Mycoses Study Group Education and H, Alexander B, Andes D, Azoulay E, quarters (for- ing platform for adolescents and young Graaf W, Pfister S, Bielle F, Journal of org/10.1002/ijc.32651 Research Consortium. Bialek R, Bradsher Jr R, Bretagne S, merly Central adults with cancer in Europe Ribalta T, Shenjere P, Preusser M, Cancer Calandra T, Caliendo A, Castagnola Office - Data Golfinopoulos V, Morfouace M, E, Cruciani M, Cuenca-Estrella M, Center) McCabe M. Decker C, Desai S, Fisher B, Harrison T, Heussel C, Jensen H, Kibbler C, EORTC Head- Access to Clinical Trials for adolescents de Rojas T., Neven A, Terada M, JNCI Cancer https://doi. Kontoyiannis D., Kullberg B, Lagrou quarters (for- and young adults with cancer: a meta- Garcia-Abos M, Moreno L, Gaspar Spectrum org/10.1093/jncics/ K, Lamoth F, Lehrnbecher T, Loef- merly Central research analysis. N, Peron J. pkz057 fler J, Lortholary O, Maertens J, Office - Data Marchetti O, Marr K, Masur H, Meis J, Center) Morrisey O, Nucci M, Ostrosky-Zeich- ner L, Pagano L, Patterson T, Racil Z, EORTC Network A multinational multi-tumour basket Peron J. , Marreaud S., Staelens European https://doi. Roilides E, Ruhnke M, Schaefer Pro- of core Institu- study in very rare cancer types: the D., Raveloarivahy T., Nzokirante- Journal of org/10.1016/j. kop C, Shoham S, Slavin M, Stevens tions (NOCI) European Organisation for Research vye A., Flament J., Steuve J., Lia Cancer ejca.2018.12.013 D, Thompson III G, Vazquez J, Viscoli and Treatment of Cancer phase II 90101 M., Collette L., Schöffski P. C, Walsh T, Warris A, Wheat L, White “CREATE” trial. L, Zaoutis T, Pappas P.

Gastrointestinal EORTC-1203-GITCG - the “INNOVATION”- Wagner A.D, Mauer M, Grabsch H, BMC Cancer https://doi. Leukemia Long-term follow-up of a trial compar- Baron F, Efficace F., Cannella L, Haematologica https://doi. Tract Cancer trial: Effect of chemotherapy alone versus Terashima M, Lordick F. org/10.1186/s12885- ing post-remission treatment with Willemze R, Vignetti M, Muus P, org/10.3324/haema- chemotherapy plus trastuzumab, versus 019-5675-4 autologous or allogeneic bone marrow Marie JP, Ferrero D, Fazi P, La tol.2019.221333 chemotherapy plus trastuzumab plus per- transplantation or intensive chemother- Sala E, Bourhis JH, Fabbiano F, tuzumab in the perioperative treatment apy in younger acute myeloid leukemia Bosi A, Sborgia M, Martinellu G, of HER-2 positive, gastric and gastro- patients. Wittnebel S, Trisolini S, Petti C, esophageal junction adenocarcinoma on Halkes C, van der Velden A. W. G., pathologic response rate: a randomized de Witte T, Amadori S, Zittoun R, phase II-intergroup trial of the EORTC- GI- Suciu S. group, Korean Cancer Study Group and Dutch Upper GI-Cancer group.

82 83 EORTC Groups Title Authors Journal DOI EORTC Groups Title Authors Journal DOI Leukemia 10-day vs 5-day decitabine: equivalence Huls G, Suciu S, Wijermans P., The Lancet https://doi. Melanoma Meta-Analysis in Metastatic Uveal Khoja L, Atenafu E, Suciu S, Annals of https://doi. cannot be concluded. Kicinski M, Lubbert M. Haematology org/10.1016/S2352- Melanoma to Determine Progression- Leyvraz S, Sato T, Marshall E, Oncology org/10.1093/annonc/ 3026(19)30024-9 Free and Overall Survival Benchmarks: Keilholz U, Zimmer L, Patel S, mdz176 an International Rare Cancers Initiative Piperno-Neumann S, Piulats Lung Cancer Definition of synchronous oligo-met- Dingemans A.M., Hendriks L., Journal of https://doi. (IRCI) Ocular Melanoma study. J, Kivelä TT, Pfoehler C, Bhatia astatic non-small cell lung cancer - a Berghmans T., Levy A., Hasan Thoracic org/10.1016/j. S, Huppert P, Van Iersel LBJ, consensus report. B., Faivre-Finn C., Giaj Levra M., Oncology jtho.2019.07.025 De Vries IJM, Penel N, Vogl T, Giaj Levra N., Girard N., Greillier Cheng T, Fiorentini G, Mouriaux L., Lantuejoul S., EDWARDS J., F, Tarhini A, Patel P, Carvajal, O’Brien M., Reck M., Smit E., Van Joshua A. Schil P., Postmus P., Ramella S., Lievens Y., Gaga M., Peled N., Melanoma Estimation of Distant Metastasis–free Eggermont A, Suciu S, Kicinski M. The New Eng- https://doi. Scagliotti G., Senan S., Paz-Ares Survival in Trials of Adjuvant Therapy for land Journal of org/10.1056/ L., Guckenberger M., McDonald Melanoma. Medicine NEJMc1902228 F., Ekman S., Cufer T., Gietema H., Infante M., Dziadziuszko R., Quality of Life Minimally important differences for Musoro J, Coens C, Fiteni F, JNCI Cancer https://doi. Peters S, Rami Porta R, Vansteen- General interpreting EORTC QLQ-C30 scores in Katarzyna P, Cardoso F, Russell Spectrum org/10.1093/jncics/ kiste J, Dooms C, De Ruysscher D, patients with advanced breast cancer. N, King M, Cocks K, Sprangers pkz037 Besse B, Novello S. M, Groenvold M, Velikova G, Flechtner H, Bottomley A, on Lung Cancer EORTC Lung Cancer Group survey on Levy A., Hendriks L., Berghmans European https://doi. behalf of the EORTC Breast and the definition of NSCLC synchronous T., Faivre-Finn C., Giaj Levra M., Journal of org/10.1016/j. Quality of Life Groups. oligometastatic disease. Giaj Levra N., Hasan B., Girard Cancer ejca.2019.09.012 N., Greillier L., Lantuejoul S., Ed- Quality of Life Impact of Radiation Target Volume on Dirven L, Reijneveld J, Taphoorn International https://doi. wards John, O’Brien M., Reck M., General Health-Related Quality of Life in Patients M, Coens C, El-Badawy S, Tzuk- Journal of org/10.1016/j. Besse B., Novello S., Dingemans With Low-Grade Glioma in the 2-Year Shina T, Bravo-Marques J, Back Radiation On- ijrobp.2019.01.003 A.M. Period Post Treatment: A Secondary M, Stalpers L, Stupp R, Baumert cology Biology Analysis of the EORTC 22033-26033. B, Seidel C. Physics Lung Cancer Defining oligometastatic non-small cell Hendriks L., Dooms C. , European https://doi. lung cancer: a simulated multidisci- Berghmans T., Novello S., Levy Journal of org/10.1016/j. Quality of Life Current state of quality of life and Bottomley A, Reijneveld J, Koller European https://doi. plinary expert opinion. A., deruysscher D., Hasan B., Giaj Cancer ejca.2019.09.013 General patient-reported outcomes research. M, Flechtner H, Tomaszewski K, Journal of org/10.1016/j. Levra M., Giaj Levra N., Besse B., Greimel E. Cancer ejca.2019.08.016 Vansteenkiste J., Dingemans A.M.

Lung Cancer Current management of limited-stage Levy A, Henkdriks L, Le Pechoux Lung Cancer https://doi. Quality of Life Symptom clusters in newly diagnosed Coomans M, Dirven L, Aaronson Neuro-Oncol- https://doi. SCLC and CONVERT trial impact: results C, Falk S, Besse B, Novello S, org/10.1016/j.lung- General glioma patients: which symptom clus- N, Baumert B, van den Bent M, ogy org/10.1093/neuonc/ of the EORTC Lung Cancer Group survey. Dingemans A.M., Hasan B, Reck can.2019.08.007 ters are independently associated with Bottomley A, Brandes A, Chinot noz118 M, Berghmans T, Faivre-Finn C. functioning and global health status? O, Coens C, Gorlia T, Herrlinger U, Keime-Guibert F, Malmstrom A, Martinelli F, Stupp R, Talacchi Lung Cancer Defining synchronous oligometastatic Giaj-Levra N, Giaj-Levra M, Journal of https://doi. A, Weller M, Wick W, Reijneveld J, non-small cell lung cancer: a systematic Durieux V, Novello S, Besse B, Thoracic org/10.1016/j. Taphoorn M . review. Hasan B, Henkdriks L, Levy A, Oncology jtho.2019.05.037 Dingemans A.M., Berghmans T. Quality of Life Prognostic value of patient-reported Mierzynska J, Piccinin C, Pe M, The Lancet https://doi. Group outcomes from international ran- Martinelli F., Gotay C, Corneel C, Oncology org/10.1016/S1470- Lung Cancer Results of a multicentre dosimetry audit Lambrecht M, Eaton D, Sonke Radiotherapy https://doi. domised clinical trials on cancer: a Mauer M, Eggermont A, Groen- 2045(19)30656-4 using a respiratory phantom within the J, Nestle U, Peulen H, Weber D, & Oncology org/10.1016/j.ra- systematic review. vold M., Bjordal K, Reijneveld J, EORTC LungTech trial. Verheij M, Hurkmans C. donc.2019.06.008 Velikova G., Bottomley A.

Melanoma Adjuvant ipilimumab versus placebo af- Eggermont A, Chiarion-Sileni V, European https://doi. Quality of Life Sensitivity to change of the EORTC qual- Weis J, Wirtz M, Tomaszewski K., Wiley Encyclo- https://doi. ter complete resection of stage III mela- Grob JJ, Dummer R, Wolchock J, Journal of org/10.1016/j. Group ity of life module measuring cancer-re- Hammerlid E, Arraras J, Conroy T, pedia org/10.1002/ noma: long-term follow-up results of the Schmidt H, Hamid O, Robert C, Cancer ejca.2019.07.001 lated fatigue (EORTC QlQ-Fa12): Results Lanceley A, Schmidt H, Singer S, pon.5151 European Organisation for Research and Ascierto P, Richards J, Lebbe C, from the international psychometric Pinto M, El-Din Alm M, Compter I, Treatment of Cancer 18071 double-blind Ferraresi V, Smylie M, Weber J, validation. Holzner B, Holfmeister D, Chie W, phase 3 randomised trial. Maio M, Hosein F, de Pril V, Kicin- Harle A, Flechtner H, Bottomley ski M., Suciu S, Testori A. A.

Melanoma Prognostic and predictive value of AJCC- Eggermont A., Blank CU, Mandala European https://doi. Quality of Life General population normative data for Nolte S, Liegl G, Petersen M, Aar- European https://doi. 8 staging in the phase III EORTC1325/ M, Long M, Atkinson V, Dalle S, Journal of org/10.1016/j. Group the EORTC QLQ-C30 health-related qual- onson N, Constantini A, Fayers P, Journal of org/10.1016/j. KEYNOTE-054 trial of pembrolizumab Haydon A, Lichinitser M, Khattak Cancer ejca.2019.05.020 ity of life questionnaire based on 15,386 Groenvold M, Holzner B, Johnson Cancer ejca.2018.11.024 vs placebo in resected high-risk stage III A, Carlino M, Sandhu S, Larkin persons across 13 European countries, C, Kemmler G, Tomaszewski K, melanoma. J, Puig S, Ascierto P, Rutkowski Canada and the Unites States. Waldmann A, Young T, Rose M. P, Schadendorf D, Koornstra R, Hernandez Aya L, Di Giacomo Quality of Life Establishing the European Norm for the Liegl G, Petersen M, Groenvold European https://doi. AM, Van Den Eertwegh A, Grob Group health-related quality of life domains of M, Aaronson N, Gonstantini G, Journal of org/10.1016/j. JJ, Gutzmer R, Jamal R, Lorigan the computer-adaptive test EORTC CAT Fayers P, Holzner B, Johnson Cancer ejca.2018.11.023 P, Lupinacci R, Krepler C, Ibrahim Core. C, Kemmler G, Tomaszewski K, N, Kicinski M., Marreaud S, van Waldmann A, Young T, Rose M, Akkooi A, Suciu S, Robert C. Nolte S.

84 85 EORTC Groups Title Authors Journal DOI EORTC Groups Title Authors Journal DOI Quality of Life German value sets for the EORTC Kemmler G, Gamper E, Nerich V, Springer https://doi. Soft Tissue and Impact of Concomitant Administration Mir O, Touati N, Lia M, Litiere S, Clinical Cancer http://doi. Group QLU‑C10D, a cancer‑specific utility in- Norman R, Viney R, Holzner B, org/10.1007/s11136- Bone Sarcoma of Gastric Acid-Suppressive Agents and Le Cesne A, Sleijfer S, Blay JY, Research org/10.1158/1078- strument based on the EORTC QLQ‑C30. King M. 019-02283-w Pazopanib on Outcomes in Soft-Tissue Leahy M, Young R, Mathijssen R, 0432.CCR-18-2748 Sarcoma Patients Treated within the Van Erp N, Gelderblom H, van der Quality of Life U.K. utility weights for the EORTC QLU- Norman R, Mercieca-Bebber R., Health Eco- https://doi. EORTC 62043/62072 Trials. Graaf W, Gronchi A. Group C10D. Rowen D, Brazier J, Cella D., Pick- nomics org/10.1002/ ard A, Street D, Viney R, Revicki hec.3950 Soft Tissue and Quality of surgery and surgical reporting Hohenberger P, Bonvalot S, European https://doi. D, King M. Bone Sarcoma for patients with primary gastrointesti- Van Coevorden F, Rutkowski Journal of org/10.1016/J. nal stromal tumours participating in the P, Stoeckle E, Olungu C, Litiere Cancer ejca.2019.07.028 Quality of Life The added value of Health-Related Coomans M, Dirven L, Aaronson European https://doi. EORTC STBSG 62024 adjuvant imatinib S, Wardelmann E, Gronchi A, Group, Brain Quality of Life (HRQoL) as a prognostic N, Baumert B, van den Bent M, Journal of org/10.1016/j. study. Casali P. Tumours indicator of overall survival and progres- Bottomley A, Brandes A, Chinot Cancer ejca.2019.05.012 sion free survival in glioma patients: a O, Coens C, Gorlia T, Herrlinger U, meta-analysis based on individual pa- Keime F, Malmstrom A, Martinelli tient data from randomized controlled F, Stupp R, Talacchi A, Weller M, trials. Wick W, Reijneveld J, Taphoorn M.

Quality of Life International validation of the revised Singer S, Amdal C, Hammerlid E, Journal of the https://doi. Group, Head European Organisation for Research and Tomaszewska I, Castro Silva J, Sciences and org/10.1002/ and Neck Treatment of Cancer Head and Neck Mehanna H, Santos M, Inhestern Specialities hed.25609 Cancer Cancer Module, the EORTC QLQ-HN43: J, Brannan C, Yarom N, Fullerton of the Head & Phase IV. A , Pinto M, Arraras J, Kiyota N, Neck Bonomo P, Sherman A, Baumann I, Galalae R, Fernandez Gonzalez L, Nicolatou-Galitis O, Abdel- Hafeez Z, Raber-Durlacher J, Schmalz C, Boehm A, Hofmeister D, Krejovic Trivic S, Loo S, Chie W, Bjordal K, Brokstad Herlofson B, Gregoire V, Licitra L., EORTC Quality of Life and the EORTC Head and Neck Cancer Groups.

Radiation On- Radiotherapy quality assurance of SBRT for Lambrecht M, Clementel E, Radiotherapy https://doi. cology (formerly patients with centrally located lung tumours Sonke J, Nestle U, Adebahr S, Gu- & Oncology org/10.1016/j.ra- Radiotherapy) within the multicentre phase II EORTC Lung- ckenberger M, Weber D, Verheij donc.2018.10.025 tech trial: Benchmark Case results. M, Hurkmans C.

Radiation On- Impact of deviations in target volume Cox S, Cleves A, Clementel E, Radiotherapy https://doi. cology (formerly delineation – Time for a new RTQA ap- Miles E, Staffurth J, Gwynne S. & Oncology org/10.1016/j.ra- Radiotherapy) proach? donc.2019.04.012

Radiation Evaluation of the Hippocampal Normal Jaap Jaspers, Alejandra Mèndez Frontiers in https://doi. Technologists Tissue Complication Model in a Pro- Romero, Mischa S. Hooge- Oncology org/10.3389/ (included in spective Cohort of Low Grade Glioma man, Martin van den Bent, Ruud fonc.2019.00991 the Radiation Patients-An Analysis Within the EORTC G. J. Wiggenraad, Martin J. B. Oncology) 22033 Clinical Trial. Taphoorn, Danielle B. P. Eek- ers, Frank J. Lagerwaard, Anna Maria Lucas Calduch, Brigitta G. Baumert and Martin Klein

Radiotherapy/ Bringing Europe together in building Weber D, Grau C, Lim P, Georg D, Acta Onco- https://doi.org/ Chemotherapy clinical evidence for proton therapy - the Lievens Y. logica 10.1080/028418 EPTN-ESTRO-EORTC endeavor. 6X.2019.1624820

Soft Tissue and Association of pazopanib-induced Vos M., Sleijfer S., Litiere S., Acta Onco- https://doi.org/ Bone Sarcoma toxicities with outcome of patients Touati N., Duffaud F., van der logica 10.1080/028418 with advanced soft tissue sarcoma; Graaf W., Gelderblom H. 6X.2019.1581376 a retrospective study based on the European Organisation for Research and Treatment of Cancer (EORTC) 62043 and 62072 clinical trials.

Soft Tissue and The impact of chemotherapy on survival Pasquali S, Pizzamiglio S , Touati European https://doi. Bone Sarcoma of patients with extremity and trunk wall N, Litiere S, Marreaud S, Bernd Journal of org/10.1016/j. soft tissue sarcoma: revisiting the results K, Gelderblom H, Stachiotti S , Cancer ejca.2018.12.009 of the EORTC-STBSG 62931 randomised Judson I, Dei Tos A, Verderio P, trial. Casali P, Woll P, Gronchi A.

86 87 CLINICAL TRIALS 2019

Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 1320 Trabectedin for recurrent grade II or III Closed to EORTC Brain EORTC Brain Tumour 26081 CODEL Phase III Intergroup Study of Radiotherapy with Regulatory in EORTC Brain EORTC Brain Tumour Group, meningioma: a randomized phase II study of the Patient Entry Tumour Group Group Concomitant and Adjuvant Temozolomide versus Process Tumour Group EORTC Radiation Oncology EORTC Brain Tumour Group Radiotherapy with Adjuvant PCV Chemotherapy Group, North Central Cancer in Patients with 1p/19q Co-deleted Anaplastic Treatment Group, Coopera- Glioma or Low Grade Glioma tive Trials Group for Neuro- 1410 INTEL- INTELLANCE 2: ABT 414 alone or ABT 414 Closed to EORTC Brain EORTC Brain Tumour Oncology, Alliance LANCE 2 plus temozolomide versus lomustine or Patient Entry Tumour Group Group temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain 10031 SOFT A Phase III Trial Evaluating the Role of LT-FU ongoing International EORTC Breast Cancer Tumour Group Ovarian Function Suppression and the Role Breast Cancer Group,International of Exemestane as Adjuvant Therapies for Study Group Breast Cancer Study Premenopausal Women with Endocrine Group,Oncology Site Man- 1410p Pediatric Evaluation of ABT-414 in Children with High Grade Closed to EORTC Brain EORTC Brain Tumour Responsive Breast Cancer tamoxifen versus agement Organization Sub 1410- Gliomas (Main study: ABT-414 alone or ABT-414 Patient Entry Tumour Group Group ovarian function suppression + tamoxifen versus BTG plus temozolomide versus lomustine for recurrent ovarian function suppression + exemestane. glioblastoma: a randomized phase II study of the EORTC Brain Tumour Group) 10041 MINDACT MINDACT (Microarray In Node-negative and 1 LT-FU ongoing EORTC Breast EORTC Breast Cancer to 3 positive lymph node Disease may Avoid Cancer Group Group,Breast Interna- 1419 ETERNITY Molecular genetic, host-derived and clinical de- Recruiting EORTC Brain EORTC Brain Tumour Chemo Therapy): A prospective, randomized tional Group,Gruppo terminants of long-term survival in glioblastoma Tumour Group Group,Brain Tumour study comparing the 70-gene signature with the Oncologico Italiano Ricer- Funders’ Collaborative common clinicpathological criteria in selecting cia Clinica,Borstkanker 1608 STEAM Study of TG02 in Elderly Newly Diagnosed or Recruiting EORTC Brain EORTC Brain Tumour patients for adjuvant chemotherapy in breast Onderzoeksgroup Adult Relapsed Patients with Anaplastic Astrocy- Tumour Group Group cancer with 0 to 3 positive nodes” Nederland,National Can- toma or Glioblastoma: A Phase Ib Study cer Research Institute - Breast Cancer Group,West German Study 1635 I-WOT IDH mutated 1p/19q intact lower grade glioma Recruiting EORTC Brain EORTC Brain Tumour Group,Grupo espanol de following resection: Wait Or Treat? Tumour Group Group estudio, tratamiento y IWOT - A phase III study otras estrategias experi- mentales en tumoures 1709 MIRAGE A phase III trial of marizomib in combination Recruiting EORTC Brain EORTC Brain Tumour solidos,SI_IOL,FNCLCC with standard temozolomide-based Tumour Group Group,North Central radiochemotherapy versus standard Cancer Treatment 10071 ALTTO A randomised, multi-centre, open-label, phase III LT-FU ongoing Breast Euro- EORTC Breast Cancer temozolomide-based radiochemotherapy alone Group,Cooperative study of adjuvant lapatinib, trastuzumab, their se- pean Adjuvant Group10,Breast European in patients with newly diagnosed glioblastoma Trials Group for Neuro- quence and their combination in patients with HER2/ Studies Team Adjuvant Studies Team - MIRAGE Oncology,Canadian ErbB2 positive primary breast cancer Cancer Trials Group 10085 Male BC Clinical and biological characterization of Male Closed to EORTC Breast Swedish Association of 26053 CATNON Phase III trial on concurrent and adjuvant temo- Closed to EORTC Brain EORTC Brain Tumour Breast Cancer : an international retrospective Patient Entry Cancer Group Breast Oncologists,EORTC zolomide chemotherapy in non-1p/19q deleted Patient Entry Tumour Group Group,EORTC Radiation EORTC, BIG and NABCG intergroup study (for the Breast Cancer Group, anaplastic glioma. The CATNON intergroup trial. Oncology Group,Medical prospective part, please refer to 10085p) Breast international Research Council Clinical Group,Schweizerisches Trial Unit,NCIC Clinical Arbeitsgemeinschaft Klin. Trial Group,Radiation Krebsforschung, Borstkanker Therapy Oncology Onderzoeksgroup Group,Cancer Trials Sup- Nederland,Cancer Trials port Unit,Cooperative Ireland Trials Group for Neuro- 10085p Prospec- Clinical and biological characterization of Male Closed to EORTC Breast Swedish Association of Oncology,University tive male Breast Cancer: an international EORTC, BIG, Patient Entry Cancer Group Breast Oncologists, EORTC College of London BC TBCRC and NABCG intergroup study. Breast Cancer Group, Breast International Group, Sch- 26071 CENTRIC Cilengitide in subjects with newly diagnosed LT-FU ongoing EORTC Brain EORTC Brain Tumour weizerisches Arbeitsgemein- glioblastoma and methylated MGMT promoter Tumour Group Group,EORTC Radiation schaft Klin.Krebsforschung, gene- a multicenter, open-label, controlled Oncology Group Borstkanker Onderzoeks- Phase III study, testing cilengitide in combination group Nederland,Cancer with standard treatment (temozolomide with Trials Ireland,Grupo Latino concomitant radiation therapy, followed by Americano de Investigações temozolomide maintenance therapy) versus Clínicas em Oncologia / Latin standard treatment alone (CENTRIC) American Cooperative On- cology Group, Translational Breast Cancer Research Con- sortium, Hellenic Oncology Research Group, Hellenic Cooperative Oncology Group

88 89 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 10112 Aphinity A randomized multicenter, double-blind, place- LT-FU ongoing Breast Interna- EORTC Breast Cancer 1502 PYTHIA A phase II study of Palbociclib plus Fulvestrant Closed to International EORTC Breast Cancer bo-controlled comparison of chemotherapy plus tional Group Group,Breast Interna- for pretreated patients with ER+/HER2- meta- Patient Entry Breast Cancer Group,International trastuzumab plus placebo versus chemotherapy tional Group static Breast Cancer; Palbociclib in molecularly Study Group Breast Cancer Study plus trastuzumab plus pertuzumab as adjuvant characterized ER-Positive/HER2 negative meta- Group therapy in patients with operable HER2-positive static Breast Study: the PYTHIA study primary breast cancer.

1513 PALLAS PALbociclib CoLlaborative Adjuvant Study: A Closed to Austrian EORTC Breast Cancer 10853 Phase III trial of radiation therapy vs no treat- LT-FU ongoing EORTC Breast EORTC Breast Cancer randomized phase III trial of palbociclib with Patient Entry Breast and Group,Breast Internation- ment for patients with in situ ductal carcinoma of Cancer Group Group adjuvant endocrine therapy versus endocrine Colorectal al Group,Austrian Breast the breast (Jointly with the EORTC Radiotherapy therapy alone for hormone receptor positive Cancer Study and Colorectal Cancer Cooperative Group) (HR+)/ human epidermal growth factor receptor Group Study Group 2 (HER2)-negative early breast Cancer 10981 AMAROS After Mapping of the Axilla:Radiotherapy Or LT-FU ongoing EORTC Breast EORTC Breast Can- Surgery Cancer Group cer Group,EORTC 1550 MINDACT Dissecting the pathways of endocrine and che- Regulatory in EORTC Breast EORTC Breast Cancer AMAROS Radiation Oncology Relapses motherapy resistance in breast cancer: Process Cancer Group Group Group22,Borstkanker A translational research project of the EORTC Onderzoeksgroup 10041/BIG 3-04 MINDACT clinical trial Nederland,ALMANAC Trialists Group 1636 PROMPT A Prospective, Multicenter, Single-Arm Cohort Regulatory in EORTC EORTC Cutaneous Lym- Study of Photopheresis in the Treatment of Process Cutaneous phoma Task Force 1307 BRAVO A phase III, randomized, open label, multicenter, Closed to EORTC Breast Swedish Association of Erythrodermic MF and SS (the PROMPT study) Lymphoma controlled trial of niraparib versus physician’s Patient Entry Cancer Group Breast Oncologists,EORTC Task Force choice in previously-treated, HER2 negative, Breast Cancer germline BRCA mutation-positive breast cancer Group,Breast Interna- patients. tional Group,Grupo 1652 PARCT Phase II trial of atezolizumab (anti-PD-L1) in the Closed to EORTC EORTC Cutaneous Lym- Espanol de Inves- treatment of stage IIb-IV mycosis fungoides/ Patient Entry Cutaneous phoma Task Force tigacion del Cancer de sezary syndrome patients relapsed/refractory Lymphoma Mama,International after a previous systemic treatment Task Force Breast Cancer Study Group,Gruppo Onco- 1221 nursing Cancer in elderly nursing home residents in Closed to EORTC Cancer EORTC Cancer in Elderly logico Italiano Ricercia home Belgium: prospective cohort study including Patient Entry in Elderly Task Task Force Clinica,Borstkanker project translational research to develop better prognos- Force Onderzoeksgroup tic tools to help with treatment decisions in the Nederland,Grupo espanol elderly de estudio, tratamiento y otras estrategias experi- 1745 APPA- A Phase II study of Adjuvant PALbociclib as an Recruiting EORTC Cancer Swedish Asso- mentales en tumoures LACHES Alternative to CHemotherapy in Elderly patientS in Elderly Task ciation of Breast solidos,Hellenic Oncology with high-risk ER+/HER2- early breast cancer Force Oncologists,EORTC Breast Research Group,Hellenic (APPALACHES) Cancer Group,EORTC Cooperative Oncology Cancer in Elderly Task Group,Icelandic Breast Force,Breast International Cancer Group,Institute Group,International of Cancer Research - Breast Cancer Study Clinical Trials & Statistics Group,Gruppo Onco- Unit,Sheba Breast Col- logico Italiano Ricer- laborative Group cia Clinica,German Adjuvant Breast Cancer Group,Grupo espanol de 1324 Olympia A randomised, double-blind, parallel group, Closed to Breast Interna- EORTC Breast Cancer estudio, tratamiento y placebo-controlled multi-centre Patient Entry tional Group Group,Breast Interna- otras estrategias experi- Phase III study to assess the efficacy and safety tional Group,National mentales en tumoures of olaparib versus placebo as adjuvant treatment Surgical Adjuvant Breast solidos,Unicancer Onco- in patients with germline BRCA1/2 mutations and and Bowel Project geriatrics Group high risk HER2 negative primary breast cancer who have 75111 Pertuzumab + trastuzumab (PH) versus PH plus Closed to EORTC Cancer Swedish Association of completed definitive local treatment and neoad- metronomic chemotherapy (PHM) in the elderly Patient Entry in Elderly Task Breast Oncologists,EORTC juvant or adjuvant chemotherapy HER2+ metastatic breast cancer population who Force Breast Cancer may continue on T-DM1 alone following disease Group,EORTC Cancer in 1401 LORD Management of low grade ductal carcinoma in Recruiting The Nether- EORTC Breast Cancer progression while on PH/PHM: an open-label Elderly Task Force situ (low-grade DCIS): a randomized, multicenter, land Cancer Group,Borstkanker multicentre randomized phase II selection trial of non-inferiority trial, between standard therapy Institute Onderzoeksgroup the EORTC Elderly Task Force and Breast Cancer approach versus active surveillance Nederland,The Nether- Group land Cancer Institute

1408 AURORA Aiming to Understand the MOlecular Aberrations Recruiting Breast Interna- EORTC Breast Cancer 1209 A phase II study exploring the safety and efficacy LT-FU ongoing EORTC Endo- EORTC Endocrine Tu- in Metastatic Breast Cancer tional Group Group,Breast Internation- of nintedanib (BIBF1120) as second line therapy crine Tumours mours Group al Group,International for patients with either differentiated or medul- Group Breast Cancer Study lary thyroid cancer progressing after first line Group therapy.

90 91 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 1203 INNOVA- INtegratioN of trastuzumab, with or without per- Recruiting EORTC Gas- EORTC Gastrointestinal Tract 40091 BOS 2 Randomized phase II trial evaluating the efficacy Closed to EORTC Gas- EORTC Gastrointestinal TION tuzumab, into periOperatiVe chemotherApy of trointestinal Cancer Group,Korean Cancer of FOLFOX alone, FOLFOX plus bevacizumab and Patient Entry trointestinal Tract Cancer Group HER-2 posiTIve stOmach caNcer: the INNOVA- Tract Cancer Study Group,Dutch Upper FOLFOX plus panitumumab as perioperative Tract Cancer TION-TRIAL Group GI Group treatment in patients with resectable liver metas- Group tases from wild type KRAS and NRAS colorectal 1409 CLIMB A prospective Colorectal Liver Metastasis Closed to EORTC Gas- EORTC Gastrointes- cancer DataBase with an Integrated Quality Assurance Patient Entry trointestinal tinal Tract Cancer program Tract Cancer Group,European Society 40CRC SPECTA- Screening Platform of the EORTC for Clinical Tri- Closed to EORTC Gas- EORTC Gastrointestinal Group of Surgical Oncology color als in Advanced Colorectal cancer “SPECTAcolor” Patient Entry trointestinal Tract Cancer Group Tract Cancer Group 1527 DREAM DREAM: Diffusion-Weighted Magnetic REsonance Recruiting EORTC Gas- EORTC Gastrointes- Imaging Assessment of Liver Metastasis to Im- trointestinal tinal Tract Cancer prove Surgical Planning Tract Cancer Group,EORTC Imag- 1201 PEACE-1 A prospective randomised phase III study of an- Closed to UNICANCER UNICANCER,EORTC Group ing Group,European drogen deprivation therapy (+/- docetaxel) with Patient Entry Genito-Urinary Cancers Society of Surgical or without local radiotherapy with or without Group,EORTC Radiation Oncology,Japan Clinical abiraterone acetate and prednisone in patient Oncology Group,Groupe Oncology Group with metastatic hormone-naïve prostate cancer. d’Etude des Tumeurs Uro- Genitales 1534 Protocol SAKK 41/13 Adjuvant aspirin treatment Recruiting Schweizeri- EORTC Gastrointes- in PIK3CA mutated colon cancer patients. A ran- sches Arbe- tinal Tract Cancer 1333 PEACE III A Randomized multicenter phase III trial compar- Recruiting EORTC Genito- EORTC Genito-Urinary domized, double-blinded, placebo-controlled, itsgemein- Group,Schweizerisches ing enzalutamide vs. a combination of Ra223 Urinary Can- Cancers Group30,Groupe phase III trial schaft Klin. Arbeitsgemeinschaft Klin. and enzalutamide in asymptomatic or mildly cers Group d’Etude des Tumeurs Uro- Krebsforsc- Krebsforschung,Central symptomatic castration resistant prostate cancer Genitales,Cancer Trials hung European Society for Anti- patients metastatic to bone. Ireland,Canadian Urolog- cancer Drug Research-EWIV ic Oncology Group,Grupo Latino Americano de 1560 ILOC Phase II of immunotherapy plus local tumour abla- Recruiting EORTC Gastro- EORTC Gastrointestinal Investigações Clínicas tion (RFA or stereotactic radiotherapy) in patients intestinal Tract Tract Cancer Group em Oncologia / Latin with colorectal cancer liver metastases Cancer Group American Cooperative Oncology Group 1607 Open-label first line, single-arm phase II study Recruiting EORTC Gas- EORTC Gastrointestinal of CisGem combined with pembrolizumab in trointestinal Tract Cancer Group patients with advanced or metastatic biliary tract Tract Cancer 1407 TIGER A Randomized phase III trial comparing con- Recruiting Alliance UNICANCER,EORTC cancer Group ventional-dose chemotherapy using paclitaxel, Genito-Urinary Cancers ifosfamide, and cisplatin (TIP) with high dose Group,Cancer Trials chemotherapy using mobilizing paclitaxel plus Ireland,Alliance,Institute 1707 VESTIGE Adjuvant immunotherapy in patients with Recruiting EORTC Gas- EORTC Gastrointestinal ifosfamide followed by High-dose carboplatin of Cancer Research - resected gastric cancer following preoperative trointestinal Tract Cancer Group and etoposide (TI-CE) as first salvage treatment Clinical Trials & Statistics chemotherapy with high risk for recurrence (N+ Tract Cancer in relapsed or refractory germ cell tumours Unit,The Australian and and/or R1): an open label randomized controlled Group New Zealand Urogenital phase-2-study (VESTIGE) and Prostate

1714 CRUCIAL Phase II trial in inoperable œsophageal cancer Recruiting EORTC Radia- EORTC Gastrointes- 1414 Pegasus Phase IIIb randomized trial comparing irradiation Recruiting EORTC Radia- EORTC Genito-Urinary evaluating the feasibility of the combination tion Oncology tinal Tract Cancer plus long term adjuvant androgen deprivation tion Oncology Cancers Group,EORTC Ra- of definitive chemoradiation with the immune Group Group,EORTC Radiation with GnRH antagonist versus GnRH agonist plus Group diation Oncology Group checkpoint blockers Nivolumab +/- Ipilimumab Oncology Group flare protection in patients with very high risk (CRUCIAL) localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG 22114 TOP GEAR Trial of preoperative therapy for gastric and Recruiting Australasian EORTC Gastroin- esophagogastric junction adenocarcinoma. A Gastro-Intes- testinal Tract Can- randomized phase II/III trial of preoperative tinal Trials cer Group,EORTC 1532 ODM-201 A phase 2 Randomized Open-Label Study of Oral Recruiting EORTC Genito- EORTC Genito-Urinary chemoradiotherapy versus preoperative chemo- Group Radiation Oncol- ODM-201 vs. androgen deprivation therapy (ADT) Urinary Can- Cancers Group therapy for resectable gastric cancer. ogy Group,Australasian with LHRH agonists or antagonist in Men with cers Group Gastro-Intestinal Trials Hormone Naive Prostate Cancer Group,Trans-Tasman Radiation Oncology 1545 EnzaRAD Randomised phase 3 trial of Enzalutamide in Closed to The Austra- EORTC Genito-Urinary Group Inc Androgen Deprivation therapy with radiation Patient Entry lian and New Cancers Group,Cancer therapy for high risk, clinically localised, prostate Zealand Uro- Trials Ireland,The Aus- cancer. genital and tralian and New Zealand 40054 PETACC-6 Preoperative chemoradiotherapy and postopera- LT-FU ongoing EORTC Gas- EORTC Gastrointestinal Prostate Urogenital and Prostate tive chemotherapy with capecitabine and oxa- trointestinal Tract Cancer Group, platin vs.capecitabine alone in locally advanced Tract Cancer EORTC Radiation Oncol- rectal cancer (PETACC-6). Group ogy Group, Federation 30072 SORCE A Phase III Randomised Double-blind Study Closed to University Col- EORTC Genito-Urinary Francophone de Cancer- Comparing Sorafenib With Placebo In Patients Patient Entry lege of London Cancers Group,University ologie Digestive, Austral- With Resected Primary Renal Cell Carcinoma at College of London asian Gastro-Intestinal High or Intermediate Risk of Relapse Trials Group, Arbeitsge- meinschaft Internistische Onkologie,Belgian Group of Digestive Oncology

92 93 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 30073 SURTIME Randomized Phase III trial comparing immediate Closed to EORTC Genito- EORTC Genito-Urinary 1735 ADHERE A randomized phase III study on maintenance On hold EORTC Head EORTC Head and Neck versus deferred nephrectomy in patients with Patient Entry Urinary Can- Cancers Group,National durvalumab vs placebo following post-operative and Neck Can- Cancer Group synchronous metastatic renal cell carcinoma. cers Group Cancer Research concomitant chemoradiation in subjects with cer Group Institute - Renal Cancer HPV-negative squamous cell head and neck Group,Canadian Urologic carcinoma (HNSCC) with high risk of recurrence: Oncology Group ADHERE

1212 NiCCC A Randomised Phase II Study of Nintedanib (BIBF Closed to Scottish Gyn- Scottish Gynaeco- 1740 LA-OSCC Randomized Phase II study of Cisplatin plus Recruiting Canadian EORTC Head and Neck 1120) compared to Chemotherapy in Patients Patient Entry aecological logical Cancer Trials Radiotherapy versus Durvalumab plus Radio- Cancer Trials Cancer Group, Canadian with Recurrent Clear Cell Carcinoma of the Ovary Cancer Trials Group,EORTC Gynecologi- therapy followed by Adjuvant Durvalumab Group Cancer Trials Group or Endometrium (NiCCC) Group cal Cancer Group versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in 1508 A phase II study of the anti-PD-L1 antibody Closed to EORTC EORTC Gynecological Intermediate Risk HPV-Positive Locoregionally atezolizumab, bevacizumab and acetylsalicylic Patient Entry Gynecological Cancer Group Advanced Oropharyngeal Squamous Cell Cancer acid to investigate safety and efficacy of this Cancer Group (LA-OSCC) combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal 24971 A randomized phase III multicenter trial of neo- Regulatory in EORTC Head EORTC Head and Neck adenocarcinoma adjuvant docetaxel (Taxotere) Process and Neck Can- Cancer Group plus cisplatin plus 5-fluorouracil versus neoadju- cer Group vant cisplatin plus 55092 Phase IB-II, open label, multicentre feasibility Closed to EORTC EORTC Gynecological 5-fluorouracil in patients with locally advanced study of Pazopanib in combination with Pacli- Patient Entry Gynecological Cancer Group inoperable squamous cell taxel and Carboplatin in patients with platinum- Cancer Group carcinoma of the head and neck refractory/resistant ovarian, fallopian tube or peritoneal carcinoma. 90111 Neoadjuvant afatinib based treatment strategies LT-FU ongoing EORTC Net- EORTC Network of Core followed by surgery in squamous cell carcinoma work of Core Institutions,EORTC Head 55994 Randomized phase III study of neoadjuvant Closed to EORTC EORTC Gynecological of the head and neck: an EORTC NOCI-HNCG Institutions and Neck Cancer Group chemotherapy followed by surgery vs. Patient Entry Gynecological Cancer Group window study concomitant radiotherapy and chemotherapy in Cancer Group FIGO Ib2, IIa > 4 cm or IIb cervical cancer. 6071 RATIFY A phase III randomized, Double-blind study of Closed to Cancer and EORTC Leukemia induction (Daunorubicin/Cytarabine) and con- Patient Entry Leukemia Group,Cancer and Leuke- 1206 A randomised phase II study to evaluate the ef- Recruiting EORTC Head UNICANCER,EORTC solidation (high-dose Cytarabine) chemotherapy Group B mia Group B ficacy and safety of Chemotherapy (CT) vs andro- and Neck Can- Head and Neck Cancer + Midostaurin (PKC 412) (IND # TBD) or Placebo in gen deprivation therapy (ADT) in patients with cer Group Group,Alliance,IRCI UK newly diagnosed patients <60 years of age with recurrent and/or metastatic, androgen receptor Salivary Gland Cancer FLT3 mutated acute myeloid leukemia (AML) (AR) expressing, salivary gland cancer (SGCs) Group,Réseau d’Expertise Français sur les Cancers ORL Rares 1301 AML21 10-day decitabine versus conventional che- Closed to EORTC Leuke- EORTC Leukemia motherapy (“3+7”) followed by allografting in Patient Entry mia Group Group,Gruppo Italiano 1219 A blind randomized multicenter study of acceler- LT-FU ongoing Danish Head EORTC Head and Neck AML patients >= 60 years: a randomized phase Malattie Ematologiche ated fractionated chemo-radiotherapy with or & Neck Cancer Cancer Group,EORTC III study of the EORTC Leukemia Group, CELG, dell’Adulto without the hypoxic radiosensitizer nimorazole Group Radiation Oncology GIMEMA and German MDS Study Group (Nimoral), using a 15 gene signature for hypoxia Group,Trans-Tasman Ra- in the treatment of squamous cell carcinoma of diation Oncology Group the head and neck Inc,Danish Head & Neck 8112 NEMO Nintedanib as maintenance treatment of malig- Recruiting EORTC Lung EORTC Lung Cancer Cancer Group nant pleural mesothelioma (NEMO): a double- Cancer Group Group blind randomized phase II study of the EORTC 1420 Best Of Phase III study assessing the “best of” radiother- Recruiting EORTC Head EORTC Head and Neck Lung Cancer Group apy compared to the “best of” surgery (trans-oral and Neck Can- Cancer Group,EORTC surgery (TOS)) in patients with T1-T2, N0-N1 cer Group Radiation Oncology 1205 EORTC randomized phase II study of pleurec- Recruiting EORTC Lung EORTC Lung Cancer oropharyngeal, supraglottic carcinoma and with Group, Schweizerisches tomy/ decortication (P/D) preceded or followed Cancer Group Group T1, N0 hypopharyngeal carcinoma Arbeitsgemeinschaft Klin. by chemotherapy in patients with early stage Krebsforschung, Groupe malignant pleural mesothelioma d’Oncologie et Radiother- apie Tete et Cou, National Cancer Research Institute 1335 SPECTA- SPECTAlung: Screening Patients with thoracic Closed to EORTC Lung EORTC Lung Cancer - Head & Neck Cancer lung tumours for Efficient Clinical Trial Access Patient Entry Cancer Group Group,EORTC Pathobiol- Grp,Interdisziplinäre AG ogy Group Kopf-Hals-Tumouren 1416 PEARLS A randomized, phase 3 trial with anti-PD-1 Recruiting EORTC Lung EORTC Lung Cancer 1559 UP- A pilot study of personalized biomarker-based Recruiting EORTC Head UNICANCER, EORTC Head monoclonal antibody pembrolizumab (MK-3475) Cancer Group Group,European Thoracic STREAM treatment strategy or immunotherapy in patients and Neck Can- and Neck Cancer Group, versus placebo for patients with early stage Oncology Platform with recurrent/metastatic squamous cell carci- cer Group National Cancer Research NSCLC after resection and completion of stan- noma of the head and neck (UPSTREAM) Institute - Head & Neck dard adjuvant therapy Cancer Grp 1417 REACTION A phase II study of etoposide and cis/carboplatin Closed to EORTC Lung EORTC Lung Cancer 1629 Late Toxicity and Long-term Quality of Life in Recruiting EORTC Head EORTC Head and Neck with or without pembrolizumab in untreated Patient Entry Cancer Group Group Head and Neck Cancer Survivors and Neck Can- Cancer Group,EORTC extensive small cell lung cancer cer Group Quality of Life Group

94 95 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 1525 NivoThym Single-arm, multicenter, phase II study of im- Closed to EORTC Lung EORTC Lung Cancer 20982 H9 Prospective controlled trial in clinical stages I-II LT-FU ongoing EORTC Lym- EORTC Lymphoma Group, munotherapy in patients with type B3 thymoma Patient Entry Cancer Group Group, European Thoracic supradiaphragmatic Hodgkin’Disease. Evalua- phoma Group Groupe d’Etudes des Lym- and thymic carcinoma previously treated with Oncology Platform tion of treatment efficacy, (long term) toxicity phomes de l’Adulte chemotherapy. and Quality of Life in two different prognostic subgroups. 1613 APPLE APPLE trial:Feasibility and activity of Closed to EORTC Lung EORTC Lung Cancer AZD9291(osimertinib) treatment on Positive Patient Entry Cancer Group Group 1208 MiniTub Minitub: Prospective registry on Sentinel Node Recruiting EORTC Mela- EORTC Melanoma Group PLasma T790M in EGFR mutant NSCLC patients (SN) positive melanoma patients with minimal noma Group SN tumour burden who undergo Completion Lymph Node Dissections (CLND) or Nodal Obser- 1702 HALT Targeted therapy with or without dose intensi- Recruiting National Can- EORTC Lung Cancer vation. fied radiotherapy for oligo-progressive disease in cer Research Group,EORTC Radiation oncogene-addicted lung tumours Institute - Oncology Group,National 1325 Adjuvant immunotherapy with anti-PD-1 mono- Closed to EORTC Mela- EORTC Melanoma Group Lung Cancer Cancer Research Institute clonal antibody Pembrolizumab (MK-3475) ver- Patient Entry noma Group Group - Lung Cancer Group sus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group 1537 COBRA Very early PET-response adapted targeted Recruiting EORTC Lym- EORTC Lymphoma Group therapy for advanced Hodgkin lymphoma: a phoma Group single –arm phase II study 1612 EBIN Combination of targeted therapy (Encorafenib Recruiting EORTC Mela- EORTC Melanoma Group and Binimetinib) followed by combination of noma Group 20012 BEACOPP BEACOPP (4 cycles escalated + 4 cycles baseline) LT-FU ongoing EORTC Lym- EORTC Lymphoma immunoterapy (Ipilimumab and Nivolumab) vs versus ABVD (8 cycles) in stage III & IV Hodgkin’s phoma Group Group,Australasian Leu- immediate combination of immunotherapy in Lymphoma kaemia and Lymphoma patients with unresectable or metastatic mela- Group,NCIC Clinical Trial noma with BRAF V600 mutation: an EORTC phase Group,Nordic Lymphoma II randomized study (EBIN) Group,Groupe d’Etudes des Lymphomes de l’Adulte,Grup per l’Estudi 18071 Adjuvant immunotherapy with anti-CTLA-4 mono- LT-FU ongoing EORTC Mela- EORTC Melanoma Group del Limfomes de Cata- clonal antibody (ipilimumab) versus placebo after noma Group lunya i Balears,National complete resection of high-risk Stage III melanoma Cancer Research Institute : A randomized, double-blind Phase 3 trial of the - Lymphoma Group-UK EORTC Melanoma Group.

20051 H10 The H10 EORTC/GELA/IIL randomized Intergroup LT-FU ongoing EORTC Lym- EORTC Lymphoma 18081 Adjuvant peginterferon alpha-2b for 2 years Closed to EORTC Mela- EORTC Melanoma trial on early FDG-PET scan guided treatment phoma Group Group,Italian Lymphoma vs Observation in patients with an ulcerated Patient Entry noma Group Group,NCIC Clinical Trial adaptation versus standard combined modality Foundation,Lymphoma primary cutaneous melanoma with T(2-4)bN0M0: Group treatment in patients with supradiaphragmatic Study Association a randomized phase III trial of the EORTC Mela- stage I/II Hodgkin’s lymphoma. noma Group

18961 Adjuvant ganglioside GM2-KLH/QS-21 Vaccina- LT-FU ongoing EORTC Mela- EORTC Melanoma Group 20113 BREACH Brentuximab vedotin associated with chemo- Closed to Lymphoma EORTC Lymphoma tion Post-operative adjuvant ganglioside GM2- noma Group therapy in untreated patients with stage I/II un- Patient Entry Study Associa- Group,Italian Lymphoma KLH/QS-21 vaccination treatment vs observation favourable Hodgkin’s lymphoma. A randomized tion Foundation,Lymphoma after resection of primary cutaneous melanoma phase II LYSA-FIL-EORTC intergroup study Study Association (AJCC stage II, T3-T4N0M0), a 2-arm multicenter randomized phase III trial

20881 H7 Phase III study on Hodgkin’s disease supradia- LT-FU ongoing EORTC Lym- EORTC Lymphoma 1514 Follow-up in Gynecological Cancer Survivors: An Recruiting EORTC Quality EORTC Gynecological phragmatic clinical stages I and II phoma Group Group,Groupe d’Etudes EORTC QLG-GCG Survivorship Study of Life Group Cancer Group,EORTC des Lymphomes de Quality of Life Group l’Adulte 1518 Confirming content validity of the EORTC QLQ- Recruiting EORTC Quality EORTC Quality of Life 20884 H3-4 Prospective randomized controlled trial of LT-FU ongoing EORTC Lym- EORTC Lymphoma C30 of Life Group Group adjuvant involved field radiotherapy after MOPP/ phoma Group Group,Pierre et Marie ABV hybrid chemotherapy in advanced Hodgkin Curie Group disease. H34 Trial 1519 Collection of Norm Data for the EORTC-CAT Closed to EORTC Quality EORTC Quality of Life Patient Entry of Life Group Group

20931 H8 Protocol H8 for a prospective controlled trial in LT-FU ongoing EORTC Lym- EORTC Lymphoma stage I-II supradiaphragmatic Hodgkin’s disease. phoma Group Group,Groupe d’Etudes Evaluation of treatment efficacy and (long term) des Lymphomes de 1521 Phase IV development of the EORTC Quality of On hold EORTC Quality EORTC Quality of Life toxicity in three different prognostic subgroups. l’Adulte Life Module for Patients with Chronic Myeloid of Life Group Group H8 Trial Leukemia (EORTC QLQ-CML24)

20971 A Phase III randomized study on low-dose total Closed to EORTC Lym- EORTC Lymphoma 1522 Development of an EORTC questionnaire for indi- Closed to EORTC Quality EORTC Quality of Life body irradiation and involved field radiotherapy Patient Entry phoma Group Group,EORTC Radiation viduals at risk for a Hereditary Cancer Predisposi- Patient Entry of Life Group Group in patients with localized stages I and II, low Oncology Group tion Syndrome : the EORTC QLQ-HCPSxx grade non-Hodgkin’s lymphoma

96 97 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 1523 Adapt the existing EORTC QLQ-GINET21 Module Closed to EORTC Quality EORTC Quality of Life 1403 rEECur International Randomised Controlled Trial of Recruiting University of EORTC Soft Tissue to develop a specific module for use in patients Patient Entry of Life Group Group Chemotherapy for the treatment of recurrent and Birmingham and Bone Sarcoma with Pancreatic Neuroendocrine Tumour. primary refractory Ewing sarcoma Group,Scandinavian Sar- coma Group,Italian Sar- coma Group,Gesellschaft 1617 Follow-up in Early and Locally Advanced Breast Regulatory in EORTC Quality EORTC Breast Cancer fuer Paediatrische Cancer Patients: An EORTC QLG-BCG- ROG Process of Life Group Group,EORTC Quality of Onko. & Haemato. - Protocol Life Group,EORTC Radia- Germany,Grupo Espanol tion Oncology Group de Investigacion en sarcomas,University of Birmingham,Swiss Paedi- 1623 Comparative evaluation of the computer-adap- Recruiting EORTC Quality EORTC Quality of Life atric Oncology Group tive EORTC quality of life measures of Life Group Group 1447 Maintenance therapy with trabectedin versus Closed to EORTC Soft EORTC Soft Tissue and 1624 An international field study for the reliability and Closed to EORTC Quality EORTC Quality of Life observation after first line treatment with doxo- Patient Entry Tissue and Bone Sarcoma Group validity of the EORTC Sexual Health Question- Patient Entry of Life Group Group rubicin of patients with advanced or metastatic Bone Sarcoma naire (EORTC SHQ-C22) for assessing sexual soft tissue sarcoma Group health in cancer patients 1506 ANITA A phase II multicenter study comparing the Closed to EORTC Soft EORTC Soft Tissue and 1722 Improving Health-Related Quality of Life in Metastat- Regulatory in EORTC Quality EORTC Breast Cancer efficacy of the oral angiogenesis inhibitor Patient Entry Tissue and Bone Sarcoma Group ic Breast Cancer. Taking stock of achievements and Process of Life Group Group,EORTC Quality of nintedanib with the intravenous cytotoxic com- Bone Sarcoma delivering better measurement Life Group pound ifosfamide for treatment of patients with Group advanced metastatic soft tissue sarcoma after 1748 Phase 1-3 development of an EORTC module as- Recruiting EORTC Quality EORTC Breast Can- failure of systemic non-oxazaphosporine-based sessing fertility issues and patient care needs of Life Group cer Group,EORTC first line chemotherapy for inoperable disease Genito-Urinary Can- “ANITA” cers Group,EORTC 1762 REDUCE Reduced dose-density of denosumab for mainte- Recruiting EORTC Soft EORTC Soft Tissue and Gynecological Cancer nance therapy of unresectable giant cell tumour Tissue and Bone Sarcoma Group Group,EORTC Lymphoma of bone: a multicenter phase II study “REDUCE” Bone Sarcoma Group,EORTC Quality Group of Life Group,European Society for Gynecological Oncology 1809 STRASS 2 A randomized phase III study of neoadjuvant che- Regulatory in EORTC Soft EORTC Soft Tissue and motherapy followed by surgery versus surgery Process Tissue and Bone Sarcoma Group alone for patients with High Risk RetroPeritoneal Bone Sarcoma 1202 Phase II trial of cabazitaxel in metastatic or Closed to EORTC Soft EORTC Soft Tissue and Sarcoma (STRASS 2) Group inoperable locally advanced dedifferentiated Patient Entry Tissue and Bone Sarcoma Group liposarcoma. Bone Sarcoma Group 62005 Phase III randomised, intergroup, international LT-FU ongoing EORTC Soft EORTC Soft Tissue and trial assessing the clinical activity of STI-571 at Tissue and Bone Sarcoma Group, two dose levels in patients with unresectable Bone Sarcoma Scandinavian Sarcoma 1317 CaboGist Phase II study of cabozantinib in patients with Closed to EORTC Soft EORTC Soft Tissue and or metastatic gastrointestinal stromal tumours Group Group, Australasian metastatic gastrointestinal stromal tumour Patient Entry Tissue and Bone Sarcoma Group (GIST) expressing the KIT receptor tyrosine Gastro-Intestinal Trials (GIST) who progressed during neoadjuvant, Bone Sarcoma kinase (CD117) Group,Italian Sarcoma adjuvant or palliative therapy with imatinib and Group Group sunitinib 62024 Intermediate and high risk localized,completely LT-FU ongoing EORTC Soft EORTC Soft Tissue 1321 ALT-GIST A randomised phase II trial of imatinib alternat- Closed to Australasian EORTC Soft Tissue and resected, gastrointestinal stromal tumours (GIST) Tissue and and Bone Sarcoma ing with regorafenib compared to imatinib alone Patient Entry Gastro-Intes- Bone Sarcoma Group, expressing KIT receptor : a controlled random- Bone Sarcoma Group,Australasian for the first line treatment of advanced gastroin- tinal Trials Scandinavian Sarcoma ized trial on adjuvant Imatinib mesylate (Glivec) Group Gastro-Intestinal Trials testinal stromal tumour (GIST). Group Group, Australasian Gas- versus no further therapy after complete surgery. Group,Italian Sarcoma (CTC 0122/AGITG AG1013GST) tro-Intestinal Trials Group Group,French Sarcoma Group,Grupo Espanol 1402 EE2012 International Randomised Controlled Trial for Closed to University of EORTC Soft Tissue de Investigacion en the Treatment of Newly Diagnosed Ewing’s Sar- Patient Entry Birmingham and Bone Sarcoma sarcomas,FNCLCC coma Family of Tumours – Euro Ewing 2012 Group,Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung,Societe Francaise Cancer et Leu- cemie des Enfants,Grupo 62092 STRASS A phase III randomized study of preoperative Closed to EORTC Soft EORTC Radiation Oncol- Espanol de Investigacion radiotherapy plus surgery versus surgery alone Patient Entry Tissue and ogy Group,EORTC Soft en sarcomas,University of for patients with Retroperitoneal sarcomas (RPS) Bone Sarcoma Tissue and Bone Sarcoma Birmingham - STRASS Group Group

98 99 Number Alias Title Status Primary Group Secondary Groups Number Alias Title Status Primary Group Secondary Groups 62113 A randomized double-blind phase II study evalu- Recruiting EORTC Soft EORTC Gynecological 22055 LUNG-ART Phase III study comparing post-operative confor- Closed to Institut Gus- Institut Gustave ating the role of maintenance therapy with cabo- Tissue and Cancer Group,EORTC mal radiotherapy to no post-operative radio- Patient Entry tave Roussy Roussy,EORTC Lung zantinib in High Grade Uterine Sarcoma (HGUtS) Bone Sarcoma Soft Tissue and Bone therapy in patients with completely resected Cancer Group,EORTC after stabilization or response to doxorubicin Group Sarcoma Group,National non-small cell lung cancer and mediastinal N2 Radiation Oncology +/- ifosfamide following surgery or in metastatic Cancer Research Insti- involvement - LUNG-ART Group,Intergroupe Fran- first line treatment tute - Gyneco Cancer cophone de Cancérologie Group,National Cancer Thoracique Research Institute - Sarco- ma Group,Gynaecological 22085 DCIS A randomized phase III study of radiation doses Closed to Trans-Tasman EORTC Breast Cancer Oncology Group and fractionation schedules for ductal carcinoma Patient Entry Radiation Group,EORTC Radiation in situ (DCIS) of the breast. Oncology Oncology Group,Breast 6083 HOVON Clofarabine added to prephase and consolida- Closed to Hemato- EORTC Leukemia Group Inc International 100 ALL tion therapy in acute lymphoblastic leukemia in Patient Entry Oncologie Group,Hemato-Oncologie Group,Trans-Tasman Ra- adults. A prospective randomized trial. Volwassenen Volwassenen Nederland diation Oncology Group Nederland Inc,Borstkanker Onder- zoeksgroup Nederland 8111 ETOP5-12 A randomised, open-label phase III trial evaluat- Closed to European Tho- EORTC Lung Cancer (SPLEN- ing the addition of denosumab to standard first- Patient Entry racic Oncology Group,European Thoracic 22113 LUNG- LungTech Stereotactic Body Radiotherapy (SBRT) Closed to EORTC Radia- EORTC Lung Cancer DOUR) line anticancer treatment in advanced NSCLC Platform Oncology Platform TECH of inoperable centrally located NSCLC: A phase Patient Entry tion Oncology Group,EORTC Radiation II study in preparation for a randomized phase Group Oncology Group III trial 1308 ROAM Radiation versus Observation following surgical Recruiting The Walton EORTC Brain Tumour 22922 Phase III randomized trial investigating the role LT-FU ongoing EORTC Radia- EORTC Breast Cancer resection of Atypical Meningioma: a randomised Centre NHS Group,EORTC Radiation of internal mammary and medial supraclavicular tion Oncology Group, EORTC Radiation controlled trial (The ROAM trial) / EORTC 1308 Foundation Oncology Group,Trans- (IM-MS) lymph node chain irradiation in stage I-III Group Oncology Group Trust Tasman Radiation Oncol- breast cancer ogy Group Inc,Cancer (Joint study of the EORTC Radiotherapy Coopera- Trials Ireland,The Walton tive Group and the EORTC Breast Cancer Coop- Centre NHS Foundation erative Group EORTC 22922/10925) Trust 22991 Three Dimensional Conformal Radiotherapy / LT-FU ongoing EORTC Radia- EORTC Radiation Oncol- 1531 ARN-509 Radiotherapy and 6-month androgen deprivation Regulatory in EORTC Radia- EORTC Radiation Oncol- Intensity Modulated Radiotherapy alone vs tion Oncology ogy Group therapy with or without Apalutamide in Interme- Process tion Oncology ogy Group Three Dimensional Conformal Radiotherapy / Group diate and Limited High Risk Localized Prostate Group Intensity Modulated Radiotherapy plus adjuvant Cancer: a phase III study hormonal therapy in localized T1b-c, T2a, N0, M0 prostatic carcinoma. A Phase III Randomized 1553 SPECTA SPECTA: Screening Cancer Patients for Efficient Recruiting Study. Clinical Trial Access 40084 A phase II-R and a phase III trial evaluating both Closed to Radiation EORTC Gastrointestinal *Erlotinib (PH II-R) and chemoradiation (PH III) Patient Entry Therapy On- Tract Cancer Group, 1553VT 1553CMT SPECTA: created for linking CMT to VISTA Trials On hold as adjuvant treatment for patients with resected cology Group EORTC Radiation Oncol- database partially used prior to Rave head of pancreas adenocarcinoma *(PH II-R ogy Group, Radiation 1604 MOTRI- Phase II open-label study with the anti-PD-L1 Recruiting Vall D’Hebron Vall D’Hebron Erlotinib randomization completed, arm 2 closed Therapy Oncology Group COLOR 3 Atezolizumab monoclonal antibody in combina- to accrual effective 04/02/14) tion with Bevacizumab in patients with advanced chemotherapy resistant colorectal cancer and 40101 POWER An open-label, randomized phase III trial of Closed to Arbeitsge- EORTC Gastrointestinal MSI-like molecular signature cisplatin and 5-fluorouracil with or without Patient Entry meinschaft Tract Cancer Group, panitumumab for patients with nonresectable, Internistische Grupo Espanol para el 1616 MOTRI- MoTriColor: A phase II study of vinorelbine in Recruiting The Nether- The Netherland Cancer advanced or metastatic esophageal squamous Onkologie Tratamiento de Tumoures COLOR 2 advanced BRAF-like colon cancer land Cancer Institute cell cancer (ESCC) Digestivos, Arbeitsge- Institute meinschaft Internistische Onkologie, Arbeitsge- 1621 A Survivorship Project to understAnd and to Regulatory in Gruppo Ital- EORTC Leukemia meinschaft Medika- impRove long-Term outcomes for Acute myeloid Process iano Malattie Group,EORTC Quality of mentöse Tumourtherapie leukemia patients (SPARTA): The SPARTA Plat- Ematologiche Life Group,Gruppo Italia- form dell’Adulto no Malattie Ematologiche 55102 ENGOT- A phase III Trial of postoperative chemotherapy Closed to Danish Gyn- EORTC Gynecological Can- dell’Adulto EN2- or no further treatment for patients with stage I-II Patient Entry aecological cer Group, Central & East- DGCG medium or high risk endometrial cancer. Cancer Group ern European Gynecologic Oncology Group, Grupo 1811 E²- EORTC-ESTRO Radiotherapy Infrastructure for Recruiting European European Society for Ra- Espanol de Investigacion RADIatE Europe Society for diotherapy and Oncology del Cancer de Ovario, Radiotherapy Multicenter Italian Trials in and Oncology Ovarian Cancer, Mario Ne- gri Gynecologic Oncology 22033 Primary chemotherapy with temozolomide LT-FU ongoing EORTC Radia- EORTC Brain Tumour Group, Danish Gynae- vs.radiotherapy in patients with low grade tion Oncology Group,EORTC Radiation cological Cancer Group, gliomas after stratification for genetic 1p loss : a Group Oncology Group,Medical Belgian Gynaecological phase III study Research Council Clinical Oncology Group, Nord- Trial Unit,NCIC Clinical Ostdeutsche Gesellschaft Trial Group,Trans-Tasman fuer Gynaekologische Radiation Oncology Onkologie, Israeli Society Group Inc,University Col- of Gyne Oncology lege of London

100 101 Number Alias Title Status Primary Group Secondary Groups 55991 A randomized trial of adjuvant treatment with LT-FU ongoing Nordic Society EORTC Gynecological radiation plus chemotherapy versus radiation of Gynecologi- Cancer Group, Nordic alone in high risk endometrial carcinoma. cal Oncology Society of Gynecological Oncology

58051 Interfant International collaborative treatment protocol Closed to Operating EORTC Children’s for infants under one year with acute lympho- Patient Entry Center for Leukemia Group,French blastic or biphenotypic leukemia Research and Acute Lymphoblastic Statistics Leukemia,Operating Center for Research and Statistics

58081 Translational research - observational study for Closed to EORTC Chil- EORTC Children’s Leuke- identification of new possible prognostic factors Patient Entry dren’s Leuke- mia Group and future therapeutic targets in children with mia Group acute lymphoblastic leukaemia (ALL).

58111 IntReALL International Study for Treatment of Standard Recruiting Charite EORTC Children’s Leuke- SR 2010 Risk Childhood Relapsed ALL 2010. A random- Universitaets- mia Group,Charite Univer- ized Phase III Study Conducted by the Resistant medizin Berlin sitaetsmedizin Berlin Disease Committee of the International BFM Study Group

58921 Randomized phase III study comparing IDA ver- LT-FU ongoing EORTC Chil- EORTC Children’s Leuke- sus MTZ in induction and intensification dren’s Leuke- mia Group treatment of AML or MDS in children mia Group

58951 The value of 1) Dexamethasone vs predniso- LT-FU ongoing EORTC Chil- EORTC Children’s Leuke- lone during induction 2) of prolonged versus dren’s Leuke- mia Group conventional duration of L-Asparaginase therapy mia Group during consolidation and late intensification, in acute lymphoblastics leukemia and lymphoblastic non-Hodgkin lymphoma of childhood. A Randomised phase III study.

58LAE Assessment of the long term outcome of child- Closed to EORTC Chil- EORTC Children’s Leuke- hood ALL patients enrolled in EORTC CLG trials Patient Entry dren’s Leuke- mia Group between 1971 and 1998 mia Group

65091 Empirical versus pre-emptive (diagnostic-driven) Closed to EORTC Infec- EORTC Leukemia antifungal therapy of patients treated for haema- Patient Entry tious Diseases Group,EORTC Infectious tological malignancies or receiving an allogeneic Group Diseases Group stem cell transplant. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups

90091 Treat CTC TRastuzumab in HER2-negative Early breast can- Closed to EORTC Net- EORTC Network of Core cer as Adjuvant Treatment for Circulating Tumour Patient Entry work of Core Institutions, UNICANCER, Cells (CTC) (“Treat CTC” trial) Institutions EORTC Breast Cancer Group, SUCCESS

90101 CREATE Cross-tumoural Phase 2 clinical trial explor- Closed to EORTC Net- EORTC Network of Core ing crizotinib (PF-02341066) in patients with Patient Entry work of Core Institutions advanced tumours induced by causal alterations Institutions of ALK and/or MET (“CREATE”)

The European Journal of Cancer is the official journal of the EORTC

102 European Organisation of Research and Treatment of Cancer (EORTC) International Association under Belgian Law. Av. E. Mounier, 83/11 1200 Brussels www.eortc.org @EORTC