A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.
Not Applicable
- Conditions
- Colon cancer
- Registration Number
- JPRN-UMIN000006541
- Lead Sponsor
- Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1.Synchronous or metachronous colorectal cancer. 2.History of hypersensitivity for capecitabine drug product component or fluorouracil. 3.Patients who need continuing use of warfarin potassium and phenytoin. 4.History of serious drug allergy (>= grade 3). 5.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure). 6.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period 7.No birth-control. 8.HIV positive. 9.Not suitable for participating in the study for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events rate
- Secondary Outcome Measures
Name Time Method 3 years disease free survival, 3 years relapse free survival, 3 years overall survival, compliance, QO