Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
Néofirinox
Randomized 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
2 other identifiers
interventional
461
1 country
36
Brief Summary
National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2012
Longer than P75 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJune 12, 2025
June 1, 2025
11.5 years
March 1, 2013
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival
To compare the 3-year disease-free survival between the investigational arm and the control arm.
3 years
Secondary Outcomes (1)
Overall survival
7 years
Study Arms (2)
Arm A : Radiotherapy + capecitabine
ACTIVE COMPARATORChemoradiotherapy 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.
Arm B : Chemotherapy then radiochemotherapy
EXPERIMENTALDrug: 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.
Interventions
Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: 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-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 CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
5 radiations per week of 2 Gy for 5 weeks
1600 mg/m² (800 mg/m² twice daily) for 5 weeks
oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
Eligibility Criteria
You may qualify if:
- Histologically proven rectal adenocarcinoma
- Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT
- Resectable tumor, or considered as potentially resectable after CRT
- No distant metastases
- Patient eligible for surgery
- Patient aged from 18 to 75 years
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2.
- No heart failure or coronary heart disease symptoms (even controlled).
- No peripheral neuropathy \> grade 1
- No prior radiotherapy of the pelvis for any reason and no previous CT
- No major comorbidity that may preclude the delivery of treatment and no active infection (HIV or chronic hepatitis B or C).
- Adequate contraception in fertile patients.
- Adequate hematologic function
- Adequate hepatic function
- Signed written informed consent
You may not qualify if:
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles
- Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
- Progressive active infection or any other severe medical condition that could jeopardize treatment administration
- Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma
- Patient included in another clinical trial testing an investigational agent.
- Pregnant or breast-feeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (36)
Centre hospitalier Universitaire d'Amiens
Amiens, France
ICO - Site Paul Papin
Angers, France
Centre hospitalier d'Auxerre
Auxerre, France
Centre Hospitalier de Beauvais
Beauvais, France
Institut de Cancérologie de Franche Comté
Besançon, France
Centre Hospitalier de Blois
Blois, France
Hopital Avicenne
Bobigny, France
Clinique Tivoli
Bordeaux, France
Hopital Saint Andre
Bordeaux, France
Institut Bergonie
Bordeaux, France
Centre Francois Baclesse
Caen, France
Chd de La Roche Sur Yon - Les Oudairies
La Roche-sur-Yon, France
Centre Bourgogne
Lille, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Hopital Prive Jean Mermoz
Lyon, France
Ap Hm - Hopital de La Timone - Adultes
Marseille, France
Institut de Cancérologie de Franche Comté
Montbéliard, France
Centre Azuréen de cancérologie
Mougins, France
Hopital Emile Muller
Mulhouse, France
centre Alexis Vautrin
Nancy, France
Polyclinique de Gentilly
Nancy, France
Centre Antoine Lacassagne
Nice, France
Groupe Hospitalier La Pitie-Salpetriere
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hopital Haut Leveque
Pessac, France
Centre Hospitalier Regional D'Annecy
Pringy, France
Hopital Robert Debre
Reims, France
Institut Jean Godinot
Reims, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Hopital Saint Gregoire
Saint-Grégoire, France
ICO - Site René Gauducheau
Saint-Herblain, France
Clinique Mutualiste de L'Estuaire
Saint-Nazaire, France
Centre Hospitalier de la Réunion - Site du GHSR
Saint-Pierre, France
Centre Paul Strauss
Strasbourg, France
Gustave Roussy
Villejuif, France
Related Publications (1)
Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
PMID: 33862000RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry CONROY, PROF
centre Alexis Vautrin les Nancy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2013
First Posted
March 5, 2013
Study Start
January 1, 2012
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
- Access Criteria
- Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.