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

Interventions: Surgery to remove residual disease and continued treatment with imatinib mesylate. Patients allocated to the intervention arm will have surgery within 4 weeks of randomisation. The preferred surgery will be a midline laparotomy, but all abdominal incisions will be allowed. All patients will be taking imatinib according to standard clinical practice for the duration of the trial. Primary outcome(s): Progression free survival, defined according to the RECIST criteria for tumour response.[For patients randomised to receive surgery: One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. For patient randomised to the control arm (no surgery): Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy