Trial Information

FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY

OBJECTIVES:

- Compare the disease-free and overall survival in patients with resectable
adenocarcinoma of the rectum treated with preoperative radiotherapy with or without
preoperative fluorouracil (5-FU) combined with leucovorin calcium (CF) and/or
postoperative 5-FU/CF.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, sex, tumor location (0-5 vs 6-10 vs 11-15 cm from anal margin), and stage (T3 vs
T4). Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients undergo involved-field radiotherapy 5 days a week for 5 weeks followed
3-10 weeks later by abdominoperineal resection or anal-sparing resection according to
local practice in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo radiotherapy as in arm I beginning on day 1 and leucovorin
calcium (CF) IV followed by fluorouracil (5-FU) IV (1 hour before radiotherapy) on days
1-5 and 29-33, followed 3-10 weeks later by resection as in arm I in the absence of
disease progression or unacceptable toxicity.

- Arm III: Patients undergo radiotherapy followed 3-10 weeks later by resection as in arm
I. Within 3-10 weeks after resection, patients receive CF followed by 5-FU on days 1-5.
Chemotherapy continues every 4 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.

- Arm IV: Patients undergo preoperative radiotherapy with concurrent chemotherapy
followed by resection as in arm II and postoperative chemotherapy as in arm III.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 992 patients will be accrued for this study within 4 years.