Colorectal Cancer
Conditions
Keywords
Colorectal Cancer
Brief summary
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.
Interventions
to receive oral uracil-tegafur 400 mg square meter for one year
PROCEDURESurgery alone
Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 75 * Performance status 0 , 1, or 2 (ECOG) * Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 * Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL * Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL
Exclusion criteria
* Prior anticancer treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival and overall survival | every course for first three courses, then every other course |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | any time |
Countries
Japan
Outcome results
None listed