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Intermediate and high risk localized,completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor : a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery.

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 08-Dec-2004
Date Step1 close: 20-Oct-2008
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 350 - All Groups: 900
Treatment Drug
Study Staff Paolo Giovanni Casali (Study Coordinator) , IRCCS - Istituto Nazionale dei Tumori, Milano
Saskia Litiere (Statistician) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels
Christine Olungu (Data Manager) , EORTC Headquarters, Brussels
Type of cancer Soft Tissue and Bone Sarcoma
Participating groups EORTC Soft Tissue and Bone Sarcoma Group
Australasian Gastro-Intestinal Trials Group
Italian Sarcoma Group
French Sarcoma Group
Grupo Espanol de Investigacion en sarcomas
Recruiting centers Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Erasmus MC (Rotterdam, Netherlands)
HELIOS Klinikum Berlin-Buch (Berlin, Germany)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Leiden University Medical Centre (Leiden, Netherlands)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Medizinische Hochschule Hannover (Hannover, Germany)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Newcastle Hospitals NHS Trust - Campus for Ageing and Vitality (Newcastle-Upon-Tyne, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UKE - University Cancer Center (Hamburg, Germany)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Universitaetsklinikum Tuebingen-Uni Kliniken Berg (Tuebingen, Germany)
University College Hospital (London, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
Protocol summary
NCT number NCT00103168
EudraCT 2004-001810-16
Financial Support Educational Grant