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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: 50 - All Groups: 78
Treatment Drug
Cabozantinib, Blind trial medication-62113
Study Staff Isabelle Ray Coquard (Study Coordinator) , Centre Leon Berard, Lyon
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
Loran De Meyer (Junior Clinical Operations Manager) loran.demeyer (at), EORTC Headquarters, Brussels
Catherine Fortpied (Unblinded statistician) catherine.fortpied (at), EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) bette.stofs (at), EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at), EORTC Headquarters, Brussels
Tim Verbiest (Data Manager) tim.verbiest (at), EORTC Headquarters, Brussels
Christophe Verstegen (Clinical Operations Manager) christophe.verstegen (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)
Fondazione IRCCS Istituto Nazionale dei Tumori (Milano, Italy)
Hospital Universitario San Carlos (Madrid, Spain)
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)
Vall d'Hebron Institut d’Oncologia (Barcelona, Spain)
Centers to be activated Centre Georges-Francois-Leclerc (Dijon, France)
Derby Hospitals NHS Foundation Trust - Royal Derby Hospital (Derby, United Kingdom)
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
Western General Hospital (Edinburgh, United Kingdom)
Protocol summary
NCT number NCT01979393
EudraCT 2013-000762-11