Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer
Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer
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 which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer.
PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to clinical stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.
Within 4-10 weeks after completion of chemoradiotherapy, patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 18 months.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the distal rectum
Located 0-9 cm from the dentate line (3-12 cm from the anal verge)
Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation
No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No other invasive malignancy within the past 5 years except:
No other serious medical illnesses
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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