Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer
Phase 2
- Conditions
- Stage III colorectal cancer
- Registration Number
- JPRN-UMIN000013185
- Lead Sponsor
- Clinical Study Group of Osaka (CSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
Not provided
Exclusion Criteria
1)Active double cancer 2)Synchronous or metachronous malignancy other than carcinoma in situ. 3)Severe postoperative complications. 4)Severe complication. 5)Severe diarrhea. 6)Severe infectious disease. 7)Medical history of severe anaphylaxis or allergia to any drug. 8)Undergoing treatment with fluorocytosine. 9)Hepatitis B virus infection, hepatitis C virus infection. 10)Women who are pregnant or breast-feeding, or Women who may become pregnant and fertile men. 11)Severe mental disorder. 12)Patients judged inappropriate for the study by their physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment Completion Rate
- Secondary Outcome Measures
Name Time Method 3-year Disease-Free Survival Overall Survival Compliance Safety