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Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
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.
Details
| Lead sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 2025 |
| Start date | 2006-10 |
| Completion | 2016-09 |
Conditions
- Colorectal Cancer
Interventions
- UFT adjuvant chemotherapy
Primary outcomes
- Disease-free survival — 9 years
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.
Countries
Japan