A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate. - ND

INTERVENTION: Pharmaceutical Form: Capsule, soft INN or Proposed INN: IMATINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: advanced gist ; MedDRA version: 9.1 Level: LLT Classification code 10053548 Term: Gastrointestinal cancer metastatic PRIMARY OUTCOME: Main Objective: Primary: to evaluate whether surgery of residual disease in patients with; advanced GIST responding to imatinib improves the progression free; survival. Primary end point(s): Primary: to evaluate whether surgery of residual disease in patients with; advanced GIST responding to imatinib improves the progression free; survival. Secondary Objective: Secondary: to correlate the pharmacokinetics of imatinib and its; metabolites in both the experimental (surgery) and standard (non‐surgery); treatment arms, with the pharmacokinetics of imatinib and metabolites; preceding randomisation. INCLUSION CRITERIA: š Histologically confirmed GIST expressing CD117+, or with documented mutation of the KIT or PDGFRA gene š Metastatic disease (liver and/or abdominal cavity); no extra‐abdominal metastases š Treatment with imatinib administered for 6‐12 months, resulting in CR, PR or SD, without PD since the start of Imatinib therapy (RECIST) š No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting š Measurable disease (RECIST) before start of imatinib š Surgically resectable residual disease (assessed on CT scan/ MRI) š Age ≥ 18 years; performance status 0 to 1 (WHO scale) š Adequate hematologic and organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range