Clinical Trial: Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatin

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.

PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare imatinib monotherapy failure free survival of patients in the two regimens.

Secondary

  • Compare relapse-free survival,relapse-free interval and overall survival in patients treated with these regimens.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients are observed (without receiving further antitumoral therapy) every 3 months for 2 years.

After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 5 years.


Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Overall survival

Original Primary Outcome:

Current Secondary Outcome:

  • Relapse-free survival
  • Relapse-free interval
  • Adverse events


Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: February 7, 2005
Date Started: December 2004
Date Completion:
Last Updated: October 28, 2013
Last Verified: October 2013