Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.
Phase 2
- Conditions
- Colon cancer
- Registration Number
- JPRN-UMIN000012618
- Lead Sponsor
- Kyushu Study group of Clinical Cancer(KSCC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of the severe hypersensitivity 2) Active other malignancies 3) Sensory neuropathy >= Grade 1 4) Diarrhea >= Grade 2 5) Active infections 6) History of mental disorder, central nerve disorder 7) Serious complication 8) Blood transfusion or hemopoietic factors (e.g. G-CSF) within 14 days 9) Pleural effusion, peritoneal fluid that needs treatment 10) Hemorrhagic diathesis, coagulation disorder 11) Patients who need flucytosine, phenytoin or warfarin potassium 12) Requiring steroid drug 13) Pregnant or lactating woman and man who hope for Partner's pregnant 14) Positive for HBs antigen and HCV antibody 15) Investigator's judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-years Disease free survival rate
- Secondary Outcome Measures
Name Time Method The rate of completion of treatment as planned Adverse event Relative dose intensity Disease free survival Overall survival