NCT03875781 Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
| NCT ID | NCT03875781 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2019-06-05 |
| Primary Completion | 2026-12-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 540 participants in total. It began in 2019-06-05 with a primary completion date of 2026-12-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 * A World Health Organization (WHO/ECOG) performance status of 0 or 1 * Informed consent signed * Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Exclusion Criteria: * Rectal tumor \> 10 cm from the anal verge on MRI (sagittal slide) * cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter * Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI) * Metastatic disease * Prior pelvic irradiation or any contraindication to pelvic irradiation * Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy * Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion. * Recent or concomitant treatment with brivudine is contraindicated * 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, * Concomitant treatment with millepertuis. * contraindication to oxaliplatin : \*bone marrow insufficiency before treatment initiation (neutrophil count \<2x109/L and/or platelet count \<100x109/L), peripheral neuropathy with permanent invalidity before treatment initiation * severe renal insufficiency (Creatinin clearance \<30 ml/min) * contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency * contraindications to capecitabin : severe renal insufficiency (Creatinin clearance \<30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase * live attenuated vaccine should not be used during and 6 months after preoperative treatment. * Previous colorectal cancer * Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years * Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * protected adults * Pregnancy or breastfeeding * Patient with no national health or universal plan affiliation coverage.
Contact & Investigator
Stéphane BENOIST, MD,PHD
STUDY CHAIR
Service de chirurgie digestive et oncologique Hôpital Bicêtre - 94275 LE KREMLIN BICETRE
Frequently Asked Questions
Who can join the NCT03875781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03875781 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 540 participants.
Is NCT03875781 currently recruiting?
Yes, NCT03875781 is actively recruiting participants. Contact the research team at stephane.benoist@aphp.fr for enrollment information.
Where is the NCT03875781 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT03875781 clinical trial?
NCT03875781 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Stéphane BENOIST, MD,PHD at Service de chirurgie digestive et oncologique Hôpital Bicêtre - 94275 LE KREMLIN BICETRE. The trial plans to enroll 540 participants.
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