A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.
- Evaluate whether surgery of residual disease improves the progression-free survival of
patients with metastatic gastrointestinal stromal tumor responding to imatinib
- Correlate the pharmacokinetics of imatinib mesylate and its metabolites before and
OUTLINE: This is a multicenter study. Patients are stratified according to center, site of
tumor origin (stomach vs small bowel vs others), and site of metastases (liver vs abdominal
cavity vs both). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgery of residual disease. Patients will then resume imatinib
mesylate therapy according to standard of care as soon as possible after surgery (as
soon as the patient restarts taking oral feeding).
- Arm II: Patients receive imatinib mesylate therapy according to standard of care.
Patients complete quality of life questionnaires at baseline; immediately after hospital
discharge (arm I only); and at 5, 11, and 23 months. Blood samples may be collected for
After completion of study therapy, patients are followed up every 3 months for 5 years and
then every 6 months.
Allocation: Randomized, Primary Purpose: Treatment
Istituto Nazionale per lo Studio e la Cura dei Tumori
United States: Federal Government