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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
to receive oral uracil-tegafur 400 mg square meter for one year
Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
National Cancer Center Hospital East
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Relapse-free survival and overall survival
Time frame: every course for first three courses, then every other course
Adverse events
Time frame: any time
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