Clinical Trial: Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Brief Summary: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.
Detailed Summary: Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.
Sponsor: Peking University
Current Primary Outcome: Rate of disease recurrence at 2 years [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rates of objective response (complete, partial, and stable) [ Time Frame: 2 years ]
- Determine the safety and tolerability of this drug in these patients. [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Peking University
Dates:
Date Received: December 27, 2010
Date Started: May 2010
Date Completion:
Last Updated: February 2, 2015
Last Verified: February 2015
