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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: 115
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 Headquarters, Brussels
Kin Jip Cheung (Unblinded COM) kin-jip.cheung (at), EORTC Headquarters, Brussels
Corneel Coens (Statistician) corneel.coens (at), EORTC Headquarters, Brussels
Laura De Meulemeester (Unblinded COM) laura.demeulemeester (at), EORTC Headquarters, Brussels
Catherine Fortpied (Unblinded statistician) catherine.fortpied (at), EORTC Headquarters, Brussels
Annika Lux (Data Manager) annika.lux (at), EORTC Headquarters, Brussels
Ellen Peeters (Project Manager) ellen.peeters (at), EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at), EORTC Headquarters, Brussels
Sofia Salgado (Regulatory Affairs Administrator) sofia.salgado (at), EORTC Headquarters, Brussels
Carla Sureda (Junior Clinical Operations Manager) carla.sureda (at), EORTC Headquarters, Brussels
Xiao Mang Zhou (Regulatory Affairs Administrator) xiao-mang.zhou (at), 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)
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)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University College Hospital (London, United Kingdom)
Centers to be activated Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Protocol summary
NCT number NCT01979393
EudraCT 2013-000762-11