Clinical trial · Interventional
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
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
NCT01804790CI-TRIAL-00090913NéofirinoxcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| mFolfirinox | Drug | — | UNRESOLVED |
| mFolfox6 or capecitabine | Drug | — | UNRESOLVED |
| Radiotherapy 50 Gy | Radiation | — | UNRESOLVED |
| TME surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A : Radiotherapy + capecitabine
- description
- 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.
- interventionNames
- Radiation: Radiotherapy 50 Gy
- Drug: Capecitabine
- Procedure: TME surgery
- Drug: mFolfox6 or capecitabine
- type
- EXPERIMENTAL
- label
- Arm B : Chemotherapy then radiochemotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Quentin Denost, Philippe Rouanet, Eva Teruel et al. · Eur J Cancer · Sep 11, 2026 · PMID 42743888 pubmed
- RESULTConroy 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 33862000