A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors
- Conditions
- Gastrointestinal stromal tumor (GIST)
- Registration Number
- JPRN-UMIN000000950
- Lead Sponsor
- Kinki GIST Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Familial GIST or GIST complicated with von Recklinghausen disease (NF type 1) 2) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years). Carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) that are judged as having been cured by local treatment is not included in active double cancer. 3) Prior chemotherapy, radiotherapy, or immunotherapy after resection of lesions 4) Prior treatment with imanitib 5) Cardiac disease assigned to NYHA class III or IV 6) Women who are pregnant, breast-feeding, or planning to become pregnant 7) Active mycosis and other infections 8) Other conditions judged as inappropriate for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence-free survival
- Secondary Outcome Measures
Name Time Method Overall survival; treatment completion rate; the relationship of mutations of c-kit and PDGFRA as well as mRNA expression of their related factors to survival period (recurrence-free survival and overall survival); and adverse events