Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
Timeline
- Start
- 1993-10-01
- Primary completion
- 2015-02
- Completion
- 2015-04
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was stopped before reaching its accrual goal due to slow accrual”
registry analysis (unspecified test); Perioperative 5-FU vs No Perioperative 5-FU; p = 0.178; Log Rank; note: one-sided log-rank test p value NCT00002525 ↗
Publications
- Results Kemeny M, Ibrahim J, Benson AB, et al.: Post-operative complications of continuous infusion 5 FU following curative resection of colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A923, 260a, 1997.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fluorouracil | Small molecule | 425 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 20 mg/m2 | Intravenous |