Completed

NéofirinoxRandomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer

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What is being tested

Radiotherapy 50 Gy

+ Capecitabine

+ TME surgery

RadiationDrugProcedure
Who is being recruted

Digestive System Diseases+8

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorUNICANCER
Last updated: June 12, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)

NCT01804790
Principal SponsorUNICANCER
Last updated: June 12, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

461 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasms by SiteRectal DiseasesColorectal NeoplasmsNeoplasmsRectal Neoplasms

Criteria

15 inclusion criteria required to participate
Adequate contraception in fertile patients
Adequate hematologic function
Adequate hepatic function
Histologically proven rectal adenocarcinoma
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11 exclusion criteria prevent from participating
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
Medical history of angina pectoris or myocardial infarction
Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice.

Group II

Experimental
Drug: Chemotherapy mFolfirinox Investigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks): oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles). Then followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

Centre hospitalier Universitaire d'Amiens

Amiens, FranceOpen Centre hospitalier Universitaire d'Amiens in Google Maps

ICO - Site Paul Papin

Angers, France

Centre hospitalier d'Auxerre

Auxerre, France

Centre Hospitalier de Beauvais

Beauvais, France
Completed36 Study Centers