Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Fluorouracil; Leucovorin; Levoleucovorin

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