Clinical Trial Details

EORTC-62005-STBSG

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Phase III randomised, intergroup, international trial assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing the KIT receptor tyrosine kinase (CD117)

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 24-Jan-2001
Date Step1 close: 08-Feb-2002
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 600
Treatment Drug
Imatinib
Study Staff Paolo Giovanni Casali (Study Coordinator) , IRCCS - Istituto Nazionale dei Tumori, Milano
Kirsten Sundby Hall (Study Coordinator) , Oslo University Hospital - Radiumhospitalet, Oslo
Jaap Verweij (Study Coordinator) , ,
John Zalcberg (Study Coordinator) , Monash University-Faculty of Medicine, Melbourne
Catherine Hermans (Data Manager) , EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Saskia Litiere (Statistician) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data 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
Italian Sarcoma Group
Centers to be activated CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00685828
NCT number NCT00685828