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Portfolio der EORTC-Studien und der Rekrutierungsstatus in Deutschland

List of studies under activation, recruiting or recently closed in Germany (cut-off date: 17/05/2021)

EORTC group (acronym) / Study Title Intergroup Status at Status in German pts #/ w/ non-EORTC EORTC Germany total pts # randomized groups? (sample size: (Yes / No) EORTC / All groups)

EORTC BRAIN TUMOR GROUP (EORTC BTG)

EORTC-1308-ROG-BTG (ROAM): Yes Recruiting Recruiting 0 / 156 Radiation versus Observation following surgical resection of Atypical (EORTC:120, All: 190) Meningioma: a randomised controlled trial. EORTC-1419-BTG Yes Recruiting Recruiting 119 / 499 Molecular genetic, host-derived and clinical determinants of long-term survival (EORTC: 230; All: 400/) in glioblastoma. EORTC-1608-BTG (STEAM): No Recruiting Recruiting 12 / 97 (81) Study of TG02 in Elderly Patients with Anaplastic Astrocytoma or Glioblastoma Multiforme. EORTC-1634-BTG (PersoMed-I): Yes Regulatory in Regulatory in 0 / 0 (205) Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Process Process Newly-Diagnosed Medulloblastoma EORTC-1635-BTG (I-WOT): No Recruiting Regulatory in 0 / 16 (450) IDH mutated 1p/19q intact lower grade glioma following resection: Wait Process Or Treat? IWOT - A phase III study EORTC-1709-BTG: Yes Closed to Closed to 75 / 749 (750) Patient Entry Patient Entry A phase III trial of marizomib in combination with standard -based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma EORTC-1926-BTG (RIGOLETTO): No Development 0 / 0 (100) Romiplostim for thrombocytopenia induced by at first progression of MGMT promoter-methylated glioblastoma: a randomized phase II open label multicenter study EORTC BREAST GROUP

EORTC-1745-BCG (APPALACHES): Yes Recruiting Recruiting 14 / 158 (366) A Phase II study of Adjuvant as an Alternative to in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES) EORTC CUTANEOUS T-CELL (EORTC CLTF)

EORTC-1636-CLTF (PROMPT): No On hold On hold 0 / 0 (43) A Prospective, Multicenter, Single-Arm Trial of Photopheresis in the Treatment of Erythrodermic MF and SS. EORTC-1754-CLTF (REACH): No Regulatory in Regulatory in 0 / 0 (71) Process Process Study to determine the aetiology of gel induced-skin drug reaction in early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL) EORTC-1820-CLTF (MOGAT): No Regulatory in Regulatory in 0 / 0 (43) Open-Label, phase II, Multi-Center, study of Anti-CCR4 Monoclonal Antibody Process Process (mogamulizumab) Plus Total Skin Electron Beam therapy (TSEB) in patients with stage IB-IIB Cutaneous T-Cell Lymphoma

EORTC GASTROINTESTINAL TRACT CANCER ROUP (EORTC GITCG)

EORTC-1203-GITCG (INNOVATION): Yes Recruiting Recruiting 58 /156 INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe (EORTC:105, All: 225) chemotherApy of HER-2 posiTIve stOmach cancer: the INNOVATION- TRIAL. EORTC-22114-40111-GITCG-ROG (TOP GEAR): Yes Recruiting Recruiting 33 / 171 (in EU) TOP GEAR: Trial of preoperative therapy for gastric and esophagogastric junction (EORTC: 211; All: 752) adenocarcinoma. A randomized phase II/III trial of preoperative chemoradiotherapy preoperative chemotherapy for resectable gastric cancer. EORTC-1527-GITCG-IG (DREAM): Yes Closed to Closed to 0 / 108 (All: 400) Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Patient Entry Patient Entry Metastasis and Improve Surgical Planning. EORTC-1534-GITCG*1: Yes Closed to Closed to 20 / 25 Protocol SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer Patient Entry Patient Entry (EORTC: 90; All: 185) patients. A randomized, double-blinded, placebo-controlled, phase III trial. EORTC group (acronym) / Study Title Intergroup Status at Status in German pts #/ w/ non-EORTC EORTC Germany total pts # randomized groups? (sample size: (Yes / No) EORTC / All groups)

EORTC-1560-GITCG (ILOC): No Closed to Closed to 0 / 23 (70) EORTC ILOC study: Phase II of immunotherapy plus local tumor ablation in Patient Entry Patient Entry patients with metastatic colorectal cancer. EORTC-1607-GITCG: No Closed to Closed to 10 / 50 (50) Open label first line, randomized phase II study of CisGem combined or not with Patient Entry Patient Entry pembrolizumab in patients with advanced or metastatic biliary tract cancer.

EORTC-1707-GITCG (VESTIGE): No Recruiting Recruiting 25 /102 (240) AdjuVant immunothErapy vS. chemoTherapy in patients with resected gastric cancer at hIGh risk of recurrence following prEoperative chemotherapy: an open label randomized controlled phase-2-study. EORTC-1714-ROG-GITCG (CRUCIAL): No Closed to Closed to 0 / 8 (130 ) Phase II trial in inoperable œsophageal cancer evaluating the feasibility Patient Entry Patient Entry of the combination of definitive chemoradiation with the immune checkpoint blockers Nivolumab +/- Ipilimumab.

EORTC GENITO-URINARY GROUP (EORTC GUCG)

EORTC-1407-GUCG*1 (TIGER): Yes Recruiting Recruiting 47 /190 (in EU)

A Randomized phase III trial comparing conventional-dose chemotherapy (EORTC: 192; All: 420) using , , and (TIP) with high dose chemotherapy using mobilizing paclitaxel plus ifosfamide followed by High-dose and (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumors. EORTC-1414-ROG-GUCG (Pegasus): No Recruiting Recruiting 6 / 243 (All: 885) Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced . A joint study of the EORTC ROG and GUCG. EORTC HEAD AND NECK CANCER GROUP (EORTC HNCG)

EORTC-1206-HNCG (IRCI 007/ADT study): Yes Recruiting Recruiting 5 / 78

A randomised phase II study to evaluate the efficacy and safety of (EORTC:114; All: 152) Chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs). EORTC-1420-HNCG*1 (Best Of): Yes Recruiting Recruiting 5 / 41 (All: 170) Phase III study assessing The “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0 oropharyngeal carcinoma. EORTC-1559-HNCG (UPSTREAM): Yes Recruiting Regulatory in 0 / 203 (All: 297) A pilot study of personalized biomarker-based treatment strategy or process immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck. EORTC-1735-HNCG (ADHERE): No Never activated Never activated 0 / 0 (650) randomized phase III study on maintenance durvalumab vs placebo following post-operative concomitant chemoradiation in subjects with HPV-negative squamous cell head and neck carcinoma (HNSCC) with high risk of recurrence: ADHERE EORTC LUNG CANCER GROUP (EORTC LCG)

EORTC-1702-LCG-ROG (HALT): Yes Recruiting Regulatory in 0 /2 (110) Targeted therapy beyond progression with or without dose-intensified process radiotHerapy in oligo-progressive disease (OPD) in oncogene Addicted Lung Tumours. EORTC MELANOMA GROUP (EORTC MG)

EORTC-1208-MG (MiniTub): No Recruiting Recruiting 9 / 284 (260) Minitub: Prospective registry on Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissections (CLND) or Nodal Observation EORTC-1612-MG (EBIN): No Recruiting Recruiting 4 / 159 (270) Combination of targeted therapy (Encorafenib and Binimetinib) followed by combination of immunoterapy (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. EORTC group (acronym) / Study Title Intergroup Status at Status in German pts #/ w/ non-EORTC EORTC Germany total pts # randomized groups? (sample size: (Yes / No) EORTC / All groups)

EORTC SOFT TISSUE AND BONE SARCOMA GROUP (EORTC STBSG)

EORTC- 1809-STBSG (STRASS 2): No Recruiting Regulatory in 0 / 7 (250) A randomized phase III study of neoadjuvant chemotherapy followed Process by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (RPS) EORTC-1976-STBSG-QLG (TOLERANCE): No Regulatory in Regulatory in 0 /0 (127) A 3 arm randomized study on healTh-related quality Of Life of EldeRly Process Process pAtients with advaNced soft tissue sarComa undergoing every three weeks or doxorubicin weekly or plus prednisolone treatment EORTC-62113-55115-STBSG-GCG (IRCI 006/HGUS): Yes Recruiting Recruiting 1 /53

A randomized phase II study evaluating the role of maintenance therapy with (EORTC: 50; All: 78) pazopanib in High Grade Uterine Sarcoma (HGUS) after stabilization or response to chemotherapy following surgery or in metastatic first line treatment. EORTC QUALITY OF LIFE (EORTC QOL)

EORTC-1514-QLQ-GCG: No Recruiting Recruiting 3 / 723 (1100) Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Protocol. 1617-QLG-BCG-ROG: No Recruiting Recruiting 0 / 227 (830) Follow-up in Early and Locally Advanced Breast Cancer Patients: An EORTC QLG-BCG- ROG Protocol MULTIPLE TUMOR TYPES

EORTC-1553 (SPECTA): No Recruiting Recruiting 0 / 1427 (/) SPECTA: Screening Patients for Efficient Clinical Trial Access. EORTC-1811 (E²-RADIatE): No Recruiting Regulatory in 0 / 728 (5000) EORTC-ESTRO Radiotherapy Infrastructure for Europe. process EORTC-1945 (OligoRARE) : No Regulatory in Regulatory in 0 / 0 (200) Process Stereotactic body radiotherapy in addition to standard of care treatment Process in patients with oligometastatic rare cancers (OligoRARE): a randomized, phase 3, open-label trial.

The information on institutions’ financial support & study drugs’ availabilities and insurance taken by the Sponsor will be provided by EORTC Clinical Operations Manager (EORTC COM) to the sites interested to participate. *1- Liaison Office is not involved in the set-up of the study; in case of questions please contact EORTC COM (COM’s contact details per EORTC study are published on EORTC website, link here) *2- EORTC sites are in other countries than Germany; accrual in Germany is through non-EORTC investigators *3- Sites selection might be ongoing or closed; investigators interested to join the study may ask the German LO to contact EORTC COM and to confirm the status C*- confidential data