JPRN-UMIN000000950
Completed
N/A
A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors - Randomized trial of adjuvant therapy with imanitib for 1 year versus 6 months in GIST patients
Kinki GIST Study Group0 sites80 target enrollmentDecember 17, 2007
ConditionsGastrointestinal stromal tumor (GIST)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastrointestinal stromal tumor (GIST)
- Sponsor
- Kinki GIST Study Group
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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