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	Closed to Patient Entry
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 Kin Jip Cheung (Unblinded COM) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Laura De Meulemeester (Unblinded COM) , EORTC Headquarters, Brussels Catherine Fortpied (Unblinded statistician) , EORTC Headquarters, Brussels Annika Lux (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Felix Oppong (Statistical Fellow) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Carla Sureda (Clinical Operations Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , 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
Recruiting centers	Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) Centre Georges-Francois-Leclerc (DIJON CEDEX, 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 - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) Institut Bergonie (Bordeaux, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, 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) University College Hospital (London, United Kingdom)
Protocol summary	http://clinicaltrials.gov/ct/show/NCT01979393
NCT number	NCT01979393
EudraCT	2013-000762-11
Financial Support	EORTC Group