Condition: Rectal Cancer · Advanced Cancer · Sponsor: Assistance Publique - Hôpitaux de Paris
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.
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
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| BENOIST | Le Kremlin-Bicêtre, Île-de-France Region, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03875781