Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
Recruitment status was Recruiting
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.
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Relapse-free interval [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
- Compare the effect of adjuvant imatinib mesylate vs observation only on the prognosis of patients with completely resected localized gastrointestinal stromal tumors at intermediate- or high-risk of relapse.
- Compare overall survival of patients treated with these regimens.
- Compare relapse-free survival and relapse-free interval in patients treated with these regimens.
- 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). Patients are randomized to 1 of 2 arms.
- 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 750 patients will be accrued for this study within 5 years.
Show 50 Study Locations
|Investigator:||Paolo G. Casali, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Investigator:||Axel Le Cesne, MD||Institut Gustave Roussy|
|Investigator:||Andres Poveda, MD||Instituto Valenciano De Oncologia|