A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000005594
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
In total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3-year disease-free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% , respectively. The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 386
Not provided
1)Active synchronous or metachronous malignancy carcinoma in situ. 2)Severe postoperative complications. 3)Severe complication. 4)Severe diarrhea. 5)Severe infectious disease. 6)Medical history of severe anaphylaxis or allergia to any drug. 7)Undergoing treatment with fluorocytosine. 8)Pregnant or lactating woman at any time during study. Men of the fertility hope. 9)Severe mental disorder. 10)Patients judged inappropriate for the study by their physicians.
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 Overall survival Adverse events, Completion rate of treatment Compliance