Spots Global Cancer Trial Database for Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
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Trial Identification
Brief Title: Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
Official Title: 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 ID: NCT00103168
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor. PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.
Detailed Description: OBJECTIVES: Primary * Assess whether there is a difference in overall survival between intermediate and high-risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus adjuvant imatinib mesylate 400 mg daily for two years Secondary * Assess whether there is a difference in relapse-free survival and relapse-free interval between GIST undergoing complete surgery alone and those undergoing surgery + adjuvant Imatinib mesylate 400 mg daily for two years. * Determine the safety of this drug in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1). * Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients are observed (without receiving further antitumoral therapy) every 3 months for 2 years. After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter. PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 3.5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Flinders Medical Centre, Bedford Park, South Australia, Australia
Herlev University Hospital, Herlev, , Denmark
Centre Hospitalier d'Abbeville, Abbeville, , France
Centre Paul Papin, Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, , France
Hopital Avicenne, Bobigny, , France
Institut Bergonie, Bordeaux, , France
Hopital Ambroise Pare, Boulogne Billancourt, , France
C.H.U. de Brest, Brest, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Hopital Louis Pasteur, Colmar, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, , France
Centre Hospitalier de Dreux, Dreux, , France
Hopital Andre Mignot, Le Chesnay, , France
C. H. Du Mans, Le Mans, , France
Hopital Robert Boulin, Libourne, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital Edouard Herriot - Lyon, Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, , France
CHU de la Timone, Marseille, , France
Centre Hospitalier General de Mont de Marsan, Mont-de-Marsan, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Centre Regional Rene Gauducheau, Nantes-Saint Herblain, , France
CHR Hotel Dieu, Nantes, , France
CHR D'Orleans - Hopital de la Source, Orleans, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hopital Bichat - Claude Bernard, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Cochin, Paris, , France
Hopital Tenon, Paris, , France
Centre Hospitalier - Pau, Pau, , France
CHU - Robert Debre, Reims, , France
Centre Hospitalier Universitaire de Rennes, Rennes, , France
Centre Eugene Marquis, Rennes, , France
Hopital Charles Nicolle, Rouen, , France
Centre Henri Becquerel, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
Institut de Cancerologie de la Loire, Saint Priest en Jarez, , France
Centre Paul Strauss, Strasbourg, , France
Hopital Universitaire Hautepierre, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Southwest German Cancer Center at Eberhard-Karls-University, Tuebingen, , Germany
Complejo Hospitalario de Leon, Leon, , Spain
Grupo Espanol de Investigacion del Cancer de Mama, Madrid, , Spain
Christie Hospital, Manchester, England, United Kingdom
Gartnavel General Hospital, Glasgow, Scotland, United Kingdom
Contact Details
Name: Paolo G. Casali, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: STUDY_CHAIR
Name: Axel Le Cesne, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: STUDY_CHAIR
Name: Andres Poveda, MD
Affiliation: Instituto Valenciano De Oncologia
Role: STUDY_CHAIR
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