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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall survival
No
Paolo G. Casali, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Unspecified
CDR0000410825
NCT00103168
December 2004
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