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

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) , EORTC Headquarters, Brussels
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
Ellen Peeters (Project Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Sofia Salgado (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Carla Sureda (Junior Clinical Operations Manager) , 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
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 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 (ST HERBALAIN 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)
Centers to be activated Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Protocol summary http://clinicaltrials.gov/ct/show/NCT01979393
NCT number NCT01979393
EudraCT 2013-000762-11
Financial Support EORTC Group