Clinical trial · Interventional
Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer
Induction Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer
NCT05868317CI-TRIAL-00066581unknownPhase 2ClinicalTrials.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)
A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction CT followed by short course RT
- description
- Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.
- interventionNames
- Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Pathologic complete response
- timeFrame
- 1 month after surgery
- description
- no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection
Secondary outcomes (3)
- measure
- Disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * World Health Organization (WHO) performance status : 0 or 1 * Histologically proven rectal adenocarcinoma \< 10 cm from anal margin on rectoscopy * clinically T3 (cT3) or clinically T4 (cT4) and/ or N+ non metastatic rectal cancer * Neutrophil count \> 1500 e/mm3 * Platelet count \>100000 * Hemoglobin \> 10 g/dl ( transfusion allowed) * Normal bilirubin level * Creatinine clearance \> 50 ml/mn Exclusion Criteria: * Distant metastases * History of chemotherapy or radiotherapy * Grade 1 neuropathy * Patient undergoing treatment for another cancer * Active infection or severe comorbidities contraindicating chemotherapy
References
Publications (2)
- RESULTFernandez-Martos C, Pericay C, Aparicio J, Salud A, Safont M, Massuti B, Vera R, Escudero P, Maurel J, Marcuello E, Mengual JL, Saigi E, Estevan R, Mira M, Polo S, Hernandez A, Gallen M, Arias F, Serra J, Alonso V. Phase II, randomized study of concomitant chemoradiotherapy followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant chemoradiotherapy and surgery in magnetic resonance imaging-defined, locally advanced rectal cancer: Grupo cancer de recto 3 study. J Clin Oncol. 2010 Feb 10;28(5):859-65. doi: 10.1200/JCO.2009.25.8541. Epub 2010 Jan 11. PMID 20065174
- 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