Status:
RECRUITING
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Rectal Cancer
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 resect...
Detailed Description
This study is a national, multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low LARC (cT3N0 or cT1-T3N+ with CRM \> 2 mm on pretreatment MRI) will be ran...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03875781
Start Date
June 5 2019
End Date
December 5 2026
Last Update
September 19 2025
Active Locations (1)
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1
BENOIST
Le Kremlin-Bicêtre, Île-de-France Region, France, 94275