EORTC-1321-STBSG

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A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST). (CTC 0122/AGITG AG1013GST)

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 02-Mar-2016 Date Step1 close: 31-Dec-2017
Data management at EORTC	No
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 50 - All Groups: 76
Treatment	Drug Imatinib, Regorafenib
Study Staff	Jean-Yves Blay (Study Coordinator) , Centre Leon Berard, Lyon Heikki Joensuu (Study Coordinator) , Helsinki University Central Hospital - Dept of Oncology, Helsinki Christian Alfano (Project Manager) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Soft Tissue and Bone Sarcoma
Participating groups	EORTC Soft Tissue and Bone Sarcoma Group Scandinavian Sarcoma Group Australasian Gastro-Intestinal Trials Group
Recruiting centers	Centre Leon Berard (Lyon, France) Gustave Roussy (VILLEJUIF CEDEX, France) Helse Bergen HF -Haukeland Hospital - Univ. Hosp (Bergen, Norway) Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Istituto Oncologico Veneto (Padova, Italy) Institut Bergonie (Bordeaux, France) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Leiden University Medical Centre (Leiden, Netherlands) Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Oulu University Hospital (Oulu, Finland) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Sahlgrenska Universitetssjukhuset (Goteborg, Sweden) Skane University Hospital (Lund, Sweden) Tampere University Hospital (Tampere, Finland) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) University College Hospital (London, United Kingdom) University Medical Center Groningen (Groningen, Netherlands)
Protocol summary	http://clinicaltrials.gov/study/NCT02365441
NCT number	NCT02365441
EudraCT	2015-001298-42
Financial Support	Educational Grant