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 Publications
| 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 |
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Institut Claudius Regaud - IUCT oncopole (Toulouse, France) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT00685828 |
| NCT number | NCT00685828 |