Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Status:
Recruiting
Trial end date:
2024-06-05
Target enrollment:
Participant gender:
Summary
This study is a non-inferiority phase III randomised trial comparing preoperative
chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in
patients with primary resectable locally advanced rectal cancer. The primary endpoint of the
study is 3-year progression free survival.
Expected 3 year PFS rate in the preoperative chemotherapy followed by chemoradiotherapy arm
is 75%. This hazard rate, in an exponential survival model, corresponds to a decrease in the
3-year PFS rate on the preoperative chemotherapy arm to 67%. The study will randomize 540
patients (270 in the chemotherapy group and 270 in the chemoradiotherapy group) in 42 french
academic centers.