Trial Information

Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

OBJECTIVES:

- Compare the pathological complete response, acute and late normal tissue morbidity,
patterns of failure, and complete resection rates in patients with locally advanced
adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy
comprised of hyperfractionated radiotherapy and fluorouracil vs conventional
radiotherapy, fluorouracil, and irinotecan, followed by radical resection.

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.

- Arm I: Patients receive hyperfractionated radiotherapy (RT) twice daily, 5 days a week
for 19 days. Patients receive fluorouracil IV continuously over 7 days a week
concurrently with RT. Patients with clinical stage T3 or fixed T4 disease also receive
a higher boost dose of RT to tumor.

- Arm II: Patients receive conventional RT once daily, 5 days a week for 25 days.
Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT.
Patients receive irinotecan IV over 1 hour (immediately prior to RT dose) once weekly
for 4 weeks. Patients with clinical stage T3 or fixed T4 disease also receive a lower
boost dose of RT to tumor.

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.