Colorectal Cancer
Conditions
Keywords
stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
Brief 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 may kill more tumor cells. It is not yet known whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer. PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.
Detailed description
OBJECTIVES: * Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation. * Compare the recurrence rates in patients treated with this regimen vs observation. * Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II). * Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks. * Arm II: Patients undergo observation. Patients are followed annually. PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Interventions
Sponsors
Institute of Cancer Research, United Kingdom
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Completely resected stage II or III colorectal cancer * No distant metastases * No positive resection margins * No positive peritoneal washings PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy in observation only arm Endocrine therapy: * Not specified Radiotherapy: * Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule Surgery: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Death from colorectal cancer | — |
| Disease recurrence | — |
Countries
United Kingdom
Outcome results
None listed