OncoMatch/Clinical Trials/NCT03875781
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Is NCT03875781 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Chemotherapy and Radiochemotherapy for rectal cancer.
Treatment: Chemotherapy · Radiochemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Disease stage
Required: Stage CT3N0, CT1N+, CT2N+, CT3N+ (clinical TNM)
cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound)
Performance status
WHO/ECOG 0–1
Prior therapy
Cannot have received: pelvic irradiation
Prior pelvic irradiation or any contraindication to pelvic irradiation
Lab requirements
Blood counts
bone marrow insufficiency before treatment initiation (neutrophil count <2x10^9/L and/or platelet count <100x10^9/L), severe bone marrow insufficiency [excluded]
Kidney function
severe renal insufficiency (Creatinin clearance <30 ml/min) [excluded]
contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection; contraindication to irinotecan: inflammatory bowel disease, bilirubin serum level > 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status > 2; contraindication to oxaliplatin: bone marrow insufficiency before treatment initiation (neutrophil count <2x10^9/L and/or platelet count <100x10^9/L), peripheral neuropathy with permanent invalidity before treatment initiation; severe renal insufficiency (Creatinin clearance <30 ml/min); contraindications to capecitabin: severe renal insufficiency (Creatinin clearance <30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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