Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study
Phase 2
- Conditions
- Colon cancer
- Registration Number
- JPRN-UMIN000006742
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 195
Inclusion Criteria
Not provided
Exclusion Criteria
1) Present with diarrhea 2) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 3) CTCAE v4.0>Grade1 of peripheral neuropathy 4) regular use of insulin 5) uncontrollable congestive heart failure, angina,hypertension, arrhythmia 6) Severe mental disease 7) active infection 8) Pregnant or breast-feeding women 9) Woman might be pregnant 10) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3 year disease free survival
- Secondary Outcome Measures
Name Time Method Completion rate of treatment,Safety, Duration of administration of oxaliplatin, Incidence of Peripheral neuropathy and hand foot syndrome, Incidence and Survival of hand foot syndrome, dose intensity,Efficacy of Stage IIIa, IIIb