Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer

• Status: Unknown status
• 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, giving the drugs in different ways, and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer.

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

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Calcium; Cobalt; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or mucinous adenocarcinoma of the rectum Distal limit of tumor no higher than 12 cm from the anal verge on proctoscopy Locally advanced (T3-4 M0) tumor by one of the following: Partial fixation Complete stenosis Invasion beyond the muscular stratum on transrectal ultrasound

PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0 or 1 Hematopoietic:

WBC greater than 3,000 Platelets greater than 130,000 Hepatic: Not specified Renal:

Creatinine less than 1.4 mg/dL Cardiovascular: No unstable angina No cardiac decompensation Other: No prior or concurrent malignancy

PRIOR CONCURRENT THERAPY: Not specified