Trial Information

A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer

OBJECTIVES:

- Compare local recurrence free rates and quality of life in patients with operable
rectal cancer receiving preoperative radiotherapy versus patients receiving selective
postoperative chemoradiotherapy.

- Determine local recurrence free survival, overall survival, time to appearance of
distant metastases, disease free survival and morbidity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by a number of
factors including surgeon.

Patients are randomized to receive preoperative radiotherapy (arm I) or postoperative
chemoradiotherapy (arm II).

- Arm I: Patients receive radiotherapy in 5 fractions over 1 week prior to surgery.
Patients undergo surgery within 7 days of the last fraction of radiotherapy.

- Arm II: Patients receive chemoradiotherapy 4-12 weeks after surgery (if circumferential
resection margins are histologically involved by tumor). Radiotherapy is administered
in 25 fractions over 5 weeks (5 days per week). During radiotherapy, patients either
receive fluorouracil (5-FU) continuous infusion, 5-FU bolus IV and leucovorin calcium
IV weekly, or a 5-day bolus schedule of 5-FU and leucovorin calcium.

Patients may then receive adjuvant chemotherapy as per local policy.

Quality of life assessments are made every 3 months for 1 year and then every 6 months for
the next 2 years.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 1800 patients will be accrued into this study.