This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PRIMARY OBJECTIVES: I. To ascertain whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with STI571 have prolonged survival compared to historical controls. SECONDARY OBJECTIVES: I. To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant STI571 following complete resection of high-risk primary GIST. II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and at the time of recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and at the time of recurrence) for scientific correlative analyses. III. To assess the toxicity of oral STI571 therapy when used in the adjuvant setting. OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 10 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Given orally
Correlative studies
American College of Surgeons Oncology Group
Durham, North Carolina, United States
Determination whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with imatinib mesylate have prolonged survival compared to historical controls
Time frame: Up to 5 years
Prevalence of recurrence free survival
Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.
Time frame: 2 years
Prevalence of recurrence
Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.
Time frame: 5 years
Overall survival
Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.
Time frame: Up to 5 years
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria
Time frame: Up to 10 years
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