RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer. PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.
OBJECTIVES: Primary * Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer. Secondary * Compare relapse-free and overall survival of patients treated with these regimens. * Compare the occurrence of adverse events in patients treated with these regimens. OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo observation. * Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,025
UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
Aichi Medical University
Aichi-gun, Aichi-ken, Japan
Japanese Red Cross Nagoya First Hospital
Nagoya, Aichi-ken, Japan
Nagoya Central Hospital
Nagoya, Aichi-ken, Japan
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, Japan
Ban Buntane Houtokukai Hospital
Nagoya, Aichi-ken, Japan
West Medical Center Jouhoku Municipal Hospital
Nagoya, Aichi-ken, Japan
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Nagoya University School of Medicine
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
...and 262 more locations
Disease-free survival
Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first.
Time frame: 9 years
Overall survival
Overall survival is defined as time from date of enrollment until date of death from any cause.
Time frame: 9 years
Types and severities of adverse events
Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.
Time frame: 15 months
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