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Goals and Specific Aims 1. Eliminate Chemotherapy for All Stage I

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Goals and Specific Aims 1. Eliminate Chemotherapy for All Stage I GCIG reviews: Delineated Process Consensus NCI US B Greer; NCI US T Trimble; AGO- review De P Harter; ANZGOG M Friedlander; elaboration by MRC-NCRI C Gourley; GICOM EM Gomez coordinator/co Garcia; MRC-NCRI A Clamp; MRC-NCRI I coordinators McNeish; ANZGOG D Rischin; MITO K N = 20 Lorusso; G Daniele; H Hal; Blagden, SP; NSGO E Avall-Lundqvist; GINECO I Ray- J.Brown, P.Pautier, M.Hensley, Coquard, SGCTG R Glasspool; ANZGOG F.Amant, M.Leitao, B.Rigaud, X.Cheng, C Lee; C Scott; JGOG D Aoki; JGOG N.Reed, P.Harter, D.Gershenson, Editing board Review by all group; SWOG M Bookman; NSGO G C.Gourley, N.Colombo, R.Glasspool, Liverpool members of Kristensen; EORTC N Ottevanger; JGOG A.Gonzalez, K.Fujiwara, E.Gomez, 10/2013 the RTWG N Susumu; G Keiichi A.Okamoto, K.Lorusso, Susumu for N = 20 N = 19 S.Sagae, A.Viswanathan, M.Seckl, and M.Friedlander,J Lederman, E Pujade- Lauraine, I Ray-Coquard, J Bryce Group Représentatives: ACRIN S Lee , Review by chairs AGO Au C Marth, AGO De J Pfisterer >, and co chairs from ANZGOG A Brand , COGI J Berek , Review by all sub committees & DGOG C Creutzberg EORTC A Casado, national from some other GEICO A Poveda, GICOM D Gallardo, groups groups such as N = 20 GINECO AC Hardy , GOG T Thigpen , ISTDD or WSN GOTIC K Fujiwara , ICORG D Donnell , N = 19 JGOG D Aoki , KGOG JW Kim , MaNGO R Fossati , MITO S Pignata , MRC-NCRI J Ledermann , NCIC CTG M Fung-Kee- Editing Cervix: S Sagae & B Monk Fung , NSGO M Mirza , RTOG D Gaffney committee Endometrial : K Lorusso & S Greggi , SGCTG N Siddiqui , SGOG R Zang , N = 20 Ovarian : P Harter & A Gonzalez NOGGO J Sehouli , PMHC A Oza J Bryce, M Friedlander, J Ledermann, A Oza, I Ray-Coquard GCIG consensus reviews update leader Co GCIG consensus review Group Coordinator Coordinator step Ov & Ut carcinosarcoma GINECO D Berton Rigaud Accepted with minor Changes low malignant potential tumors AGO P Harter Submitted low grade serous carcinoma GOG D Gershenson C Gourley Submitted Sex cord tumor GINECO I Ray Coquard N Colombo Submitted germ Cell Tumor GOG J Brown M Seckl Submitted squamous Ov carcinoma SGCTG R Glasspool Antonio Gonzales Submitted Small Cell carcinoma cervix GOTIC K Fujiwara N Reed Accepted with some comments small cell carcinoma OV EORTC N Reed P Pautier Submitted vulvar & vagina melanoma US NCI M Leitao Xi Cheng Accepted ovarian carcinoid tumor GICOM N Reed E Gomez Submitted Mucinuous carcinoma MRC/NCRI J Ledermann J Brown Submitted clear cell carcinoma Ovary JGOG A Okamoto R Glasspool Just submitted clear cell carcinoma Cervix & Ut GOTIC K Fujiwara & Dr Hasegawa Need to be submitted trophoblastic diseases MITO K Larusso M Seckl Submitted low grade endometrial stromal sarcoma EORTC F Amant Submitted HG uterine sarcoma GINECO P Pautier Submitted uterine serous carcinoma JGOG S Sagae A Viswanathan Need to be submitted adenosarcoma ANZGOG M Friedlander Accepted with minor changes Ut & Ov leiomyosarcoma US NCI M Hensley Submitted glandular carcinoma of cervix GOTIC K Fujiwara B Monk Submitted Next steps for consensus reviews documents Publications : Publications on website and in journal One paper summarizing all documents (non answered questions) in progress 20 papers in a supplement (Int J Gyn Cancer) to be finalized What place for rare tumors in the 5th OCCC, Japan 2015? A special team will be designed to help the Chairs The most easy part of the job is made, the next will be really more difficult (updating, implementation …) Updating: Every 3 years for paper version Every year for website version (addendum will be posted if needed) Current coordonator will be asked to be the sentinel for the next 3 years Implementation within national group: Experiences will be reported next meeting GCIG RTWG meeting London Nov. 2013, first step Objectives: To define current recommendations for rare gynecologic tumors; To help to define control arm for present and future clinical trials involving rare cancer; To identify national & international barriers for trials dedicated to rare gynecologic cancers To summarize and prioritize key issues for research and agree new set of trial concepts to address the key issues in several rare tumors To prioritize and design 3 international initiatives in rare gynecologic cancer GCIG Rare Tumors project, the future Publications: one paper to summarize London meeting (500 words per section) harmonization, statistical, biology and specific recommendations for very very rare, rare and not so rare disease (cut-off date Sept 2014) More dedicated projects to rare gynecologic cancer = Limited resources imply concerted actions Combination of clinical trials and other projects (specific databases & tumor collections) Next tasks to be delivered: Cervix proposals will be sent to Cervix subgroups for considerations Carcinosarcoma is on –going to be delineated with Phase II group New Proposals adapted to rare diseases/situations A specifc session is anticipated bringing pathologists & clinicians to delineate recommendations for inclusion of patients in clinical trials with rare tumors (ESGO 2015) ALIENOR DESIGN : 60 patients Standard Arm A R Paclitaxel alone of care A Standard PD or N Toxicity D 80mg/m², IV, at D1, D8 and D15 surveillance O every 4 weeks Bevacizumab M 15mg/Kg every 3 weeks I S At the investigator discretion A T I Paclitaxel O 80mg/m², IV, D1, D8 and D15 N every 4 weeks Bevacizumab PD or Standard Arm B + Toxicity 15mg/Kg every 3 weeks of care Bevacizumab 10mg/kg, IV, D1 and D15 Maximum of 6 cycles Up to 1 year or until PD / intolerance Population : Patients with an histologically Stratification confirmed diagnosis of Primary objective : Anterior chemotherapy lines : Clinical benefit rate 1 or 2 vs 3 and more ovarian sex-cord stromal Platinum Free Interval Interval (PFI) tumor in relapse after a (non-progression rate after <12 months vs >12 months platinum-based 6 months of treatment) chemotherapy. 7 ALIENOR - Satellite Meeting More details during the satellite meeting (13:30 to 14:00) 70 60 50 40 AGO 04/04/2014 Planned 30 Actual 20 20 GINECO First Patient In 28/02/2013 10 0 • Enrollment period : 36 months First Patient In : February 2013 • Treatment + maintenance : 18 months Last Patient Out of Maintenance : August 2017 • Follow-up : 36 months Last Patient Out : August 2020 ALIENOR - Satellite Meeting 8 NiCCC Nintedanib in Clear Cell Carcinoma A Randomised Phase II Study of BIBF 1120 versus Chemotherapy in Recurrent Clear Cell Carcinoma of the Ovary or Endometrium SGCTG/NCRI/NSGO NiCCC Trial Design Chemotherapy Ovary: R •PLDH (40mg/m2 day 1q28) 90 pts with A •Weekly Paclitaxel (80mg/m2 day 1, 8, 15 q28) progressive or N •Weekly Topotecan iv (4mg/m2 day 1, 8, 15 q28) relapsed CCC of ovary within 6 D Endometrium: months of O •Carboplatin (AUC 5) /Paclitaxel 175 mg/m2 q21 previous platinum. M •Doxorubicin 60mg/m2 q21 Plus up to 30 I women with S endometrial CCC Nintedanib 200mg bd until E progression Primary Endpoint: PFS Secondary Endpoints: OS, Toxicity, RR, QoL, Q-Twist SOON OPEN FOR INCLUSION AUGUST 2014 Paragon trial: Phase II study of aromatase inhibitors in women with 11 potentially hormone responsive recurrent/metastatic gynaecological neoplasms SCREENING Metastatic or recurrent ER+ve and/or PR+ve gynaecological cancer Epithelial ovarian cancer Endometrial Endometrial Granulosa 1. Rising CA125 after 1st line cancer stromal sarcomas cell/sex cord therapy (closed to further (closed to stromal tumours accrual) further accrual) and other 2. Recurrent low grade ovarian gynaecological Suitable for • cancersThere are currently 23 sites recruiting across Australiasarcomas & New Zealandendocrine therapy 3. Platinum(ANZGOG) resistant/refractory with a further 21 in the United Kingdom (CRUK) • Current accrual 255 from a target of 350 REGISTRATION PROCEDURES • Of the seven tumour subgroups,Signed theinformed Epithelial consent Ovarian cancer - Platinum Resistant / Refractory and Endometrial subgroups have completed accrual • All other tumour subgroups remainTREATMENT open to recruitment. Anastrozole (1 mg daily) • Accrual expectedStudy to visits close monthly Dec for2015 first 3 months then every 3 months Tumour markers at each visit (if initially elevated) & imaging every 3 months in patients with measurable disease GCIGHyatt Meeting, Canberra Chicago, | 26–29 MayMarch 2014 2014 GOG 0281/LOGS Trial • Phase II/III • International trial: UK (NCRI) and US (NRG) • Target sample size = 250 pts • Activated in US 2-14 • Crossover design Assessments N = 250 patients Clinical: Primary endpoint: PFS LOGS Study Trial Schema • At screening day 1 of each Secondary endpoints: cycle • Adverse effects • Following disease • Objective response progression, pts will be • Overall survival followed every 12 wk • Molecular analyses CT Scans: • Quality of Life Screening, then every 8 wk R until disease progression Arm B = Experimental Arm Arm A = Control Arm Trametinib 2 mg po daily Investigators Choice of following: continuous treatment • Letrozole 2.5 mg po qd continuously For each arm, 1 cycle = 28 days • Tamoxifen 20 mg po bid continuously • Paclitaxel 80 mg/m2 IV over 1 hr on day Competitive1 q. 7d, 3trials wks on, on 1 wk-going: off • Pegylated Liposomal Doxorubicin 40 or - MILO50 trial mg/m 2 IV over 1 hr on day 1 q. 28d • Topotecan 4.0 mg/m2 over 30 min on - Merckdays trial 1, 8 and(Mek 15 of inhibitor a 28 day cycle plus or less PI3k inh) For each arm, 1 cycle = 28 days The RTWG highlighted how important and constructive could be to have an academic steering committee across the 3 RCT to support and help the development of
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