Intermediate and high risk localized , completely resected, gastrointestinal stromal tumors ( GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate ( Glivec) versus no further therapy after complete surgery.
Phase 1
- Conditions
- To assess whether mesylate, as an adjunct to complete surgery, is able to improve prognosis of patients with intermediate and high risk localized GIST.
- Registration Number
- EUCTR2004-001810-16-ES
- Lead Sponsor
- EORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 908
Inclusion Criteria
Histologically proven diagnosis of GIST
Surgery performed from 2 weeks to 3 months before randomization
Patients with R0 or R1 resection are eligibles
Absence odf distant metastases
Age > 18 years old.
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)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subjects with metastase disease
Subjects with evidence of residual macroscopic disease after surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether threr is a difference in overall survival between intermediate and high risk localized GIST pateints undergoing complete surgery plus adjuvant Imatinib mesylate 400 mg daily for two years. ;Secondary Objective: To assess whether ther is a difference in relapse- free survival and relapse- free interval between intermediate and high risk localized GIST patients undergoing complete surgery alone and those undergoning complete surgry plus adjuvant Imatinib 400 mg daily for teo years. ;Primary end point(s): Overall survival
- Secondary Outcome Measures
Name Time Method