Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer|
- Disease-free survival [ Time Frame: 9 years ] [ Designated as safety issue: No ]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.
- Overall survival [ Time Frame: 9 years ] [ Designated as safety issue: No ]Overall survival is defined as time from date of enrollment until date of death from any cause.
- Types and severities of adverse events [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2006|
|Study Completion Date:||September 2016|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Active Comparator: UFT adjuvant therapy group
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. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
Drug: UFT adjuvant chemotherapy
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.
Other Name: Adjuvant chemotherapy with tegafur-uracil
No Intervention: Observation group
Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
- Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392899
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|Study Chair:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|