Actively Recruiting
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15
540
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven middle or low rectal carcinoma, 10 cm or less from the anal verge on MRI
- Tumor stage cT3N0 and/or cT1-T3N+ on pretreatment imaging
- Pretreatment circumferential margin greater than 2 mm on MRI
- Age 18 years or older
- WHO/ECOG performance status of 0 or 1
- Signed informed consent
- Use of effective birth control during treatment and for at least 6 months after if of childbearing potential
You will not qualify if you...
- Rectal tumor located more than 10 cm from the anal verge on MRI
- Tumor staged as cT4 or involving the external sphincter
- Circumferential margin 2 mm or less on pretreatment MRI
- Presence of metastatic disease
- Prior pelvic irradiation or contraindication to pelvic irradiation
- Contraindications to oxaliplatin, irinotecan, or 5-FU based chemotherapy
- Current treatment with warfarin (unless replaced)
- Recent or current treatment with brivudine
- Contraindications to 5-FU including severe enzyme deficiency, bone marrow insufficiency, or severe infection
- Contraindications to irinotecan including inflammatory bowel disease, high bilirubin levels, severe bone marrow issues, or poor performance status
- Contraindications to oxaliplatin including bone marrow insufficiency or severe neuropathy
- Severe renal insufficiency (creatinine clearance below 30 ml/min)
- Contraindications to folinic acid including certain types of anemia
- Contraindications to capecitabine including severe renal insufficiency or enzyme deficiency
- Use of live attenuated vaccines during and 6 months after treatment
- Previous colorectal cancer
- Other concurrent or past cancers except certain skin or cervical cancers or those in remission over 5 years
- Any conditions that could interfere with study compliance
- Protected adults
- Pregnancy or breastfeeding
- Lack of national health or universal insurance coverage
AI-Screening
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Trial Site Locations
Total: 1 location
1
BENOIST
Le Kremlin-Bicêtre, Île-de-France Region, France, 94275
Actively Recruiting
Research Team
S
Stéphane BENOIST, MD,PHD
CONTACT
A
Antoine BROUQUET, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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