Clinical Trial Details
EORTC-62113-55115-STBSG-GCG
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A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment
Study documentation Publications
| Trial Status | Recruiting |
|---|---|
| Dates |
Date of activation: 30-Jan-2015 |
| Data management at EORTC | Yes |
| Design |
Phase 2 Randomized blind |
| Targeted Sample size | EORTC Groups: 85 - All Groups: 108 |
| Treatment |
Drug Cabozantinib, Blind trial medication-62113 |
| Study Staff |
Isabelle Ray Coquard (Study Coordinator) , Centre Leon Berard, Lyon Maarten Caspers (Data Manager) maarten.caspers (at) eortc.org, EORTC Headquarters, Brussels Kin Jip Cheung (Unblinded COM) kin-jip.cheung (at) eortc.org, EORTC Headquarters, Brussels Corneel Coens (Statistician) corneel.coens (at) eortc.org, EORTC Headquarters, Brussels Laura De Meulemeester (Unblinded COM) laura.demeulemeester (at) eortc.org, EORTC Headquarters, Brussels Catherine Fortpied (Unblinded statistician) catherine.fortpied (at) eortc.org, EORTC Headquarters, Brussels Fiona Namanya (Clinical Operations Assistant) fiona.namanya (at) eortc.org, EORTC Headquarters, Brussels Ellen Peeters (Project Manager) ellen.peeters (at) eortc.org, EORTC Headquarters, Brussels Sofia Salgado (Regulatory Affairs Administrator) sofia.salgado (at) eortc.org, EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) bette.stofs (at) eortc.org, EORTC Headquarters, Brussels Carla Sureda (Junior Clinical Operations Manager) carla.sureda (at) eortc.org, EORTC Headquarters, Brussels Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at) eortc.org, EORTC Headquarters, Brussels Xiao Mang Zhou (Regulatory Affairs Administrator) xiao-mang.zhou (at) eortc.org, EORTC Headquarters, Brussels |
| Type of cancer | Uterine |
| Participating groups |
EORTC Gynecological Cancer Group EORTC Soft Tissue and Bone Sarcoma Group National Cancer Research Institute - Gyneco Cancer Group National Cancer Research Institute - Sarcoma Group Gynaecological Oncology Group |
| Recruiting centers |
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) Centre Georges-Francois-Leclerc (Dijon, France) Centre Leon Berard (Lyon, France) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario San Carlos (Madrid, Spain) IRCCS - Istituto Nazionale dei Tumori (Milano, Italy) Institut Bergonie (Bordeaux, France) Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Universitaetsklinikum Tuebingen-Uni Kliniken Berg (Tuebingen, Germany) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University College Hospital (London, United Kingdom) |
| Centers to be activated |
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) IRCCS - Istituto Nazionale dei Tumori (Milano, Italy) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT01979393 |
| NCT number | NCT01979393 |
| EudraCT | 2013-000762-11 |