Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer

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

Trial Details

NCT ID
NCT03875781
Phase
PHASE3
Sponsor
Assistance Publique - Hôpitaux de Paris
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Chemotherapy
  • Radiochemotherapy
Locations (sample)
  • Le Kremlin-Bicêtre, Île-de-France Region, France|48.81471,2.36073

Key Eligibility Criteria

  • Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)
  • cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound),
  • Pretreatment predictive circumferential margin \> 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
  • Patients must be 18 years old or older

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →