← Eichor
Study identifier: NCT03875781 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Rectal Cancer · Advanced Cancer  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 3
Planned participants540
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Stéphane BENOIST, MD,PHD  ·  + 33 1 45 21 34 72  ·  stephane.benoist@aphp.fr

Antoine BROUQUET, MD,PHD  ·  + 33 1 45 21 34 70  ·  antoine.brouquet@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

BENOISTLe Kremlin-Bicêtre, Île-de-France Region, FranceRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT03875781