Trial Information

RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA

OBJECTIVES: I. Assess the local recurrence rate, cost-benefit ratio, and acute and late
toxicity associated with concomitant preoperative radiotherapy and fluorouracil/leucovorin
(5-FU/CF) in patients with locally advanced adenocarcinoma of the rectum. II. Compare the
relapse rate, survival rate, disease-free interval, and cost-benefit ratio associated with 6
courses of postoperative 5-FU/CF vs. no further treatment in these patients.

OUTLINE: This is a randomized study. Patients are stratified by tumor stage, age, type of
surgery, and participating institution. Patients are randomly assigned to one of two groups.
The first group receives radiotherapy to the tumor over 5 weeks and concomitant
fluorouracil/leucovorin for 5 consecutive days on the first and fifth weeks. Four to six
weeks later, patients undergo complete resection, followed upon recovery by
fluorouracil/leucovorin every 4 weeks for 6 courses. The second group receives preoperative
chemoradiotherapy followed by surgery, as above, with no postoperative treatment. Patients
are followed for survival.

PROJECTED ACCRUAL: A total of 774 patients will be entered on this multicenter study.