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Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Gastrointestinal Stromal Tumor Clinical Trial

Official title:
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01267695
Study type Interventional
Source Peking University
Contact
Status Completed
Phase Phase 2
Start date May 2010
Completion date October 2014
View Details
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