Overview

Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical Research Council
Collaborator:
NCIC Clinical Trials Group
Treatments:
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumor
within 15 cm of anal verge)

- Tumor considered potentially operable

- No evidence of metastases indicated by liver ultrasound or CT scan; chest x-ray; or
renal, liver, and bone profiles

PATIENT CHARACTERISTICS:

Age:

- 75 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No uncontrolled heart failure or angina

Other:

- No other concurrent uncontrolled medical illness (e.g., infection)

- No other prior or concurrent malignancy likely to interfere with the protocol
treatments or comparisons

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified