Clinical trial · Interventional
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
NCT06812728CI-TRIAL-00086204recruitingPhase 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 phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox 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 |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| mFolfox6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (mFolfox6)
- description
- Chemotherapy (mFolfox6) then radiochemotherapy
- interventionNames
- Drug: mFolfox6
- type
- EXPERIMENTAL
- label
- Arm B (mFOLFIRINOX)
- description
- Chemotherapy (mFOLFIRINOX) then radiochemotherapy
- interventionNames
- Drug: mFOLFIRINOX
Primary outcomes (1)
- measure
- Complete clinical response rate
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven rectal adenocarcinoma. 2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT. 3. Resectable tumor, or considered as potentially resectable after CRT. 4. No distant metastases. 5. Patient eligible for surgery 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1. 7. No heart failure or coronary heart disease symptoms (even controlled). 8. No peripheral neuropathy \> grade 1. 9. No prior radiotherapy of the pelvis for any reason and no previous CT 10. No major comorbidity that may preclude the delivery of treatment 11. Adequate contraception in fertile patients. 12. Adequate hematologic function. 13 Adequate hepatic function. 14\. Signed written informed consent. Exclusion Criteria: 1. Metastatic disease 2. 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 3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum 4. Medical history of angina pectoris or myocardial infarction 5. Other concomitant cancer. 6. Pregnant or breast-feeding woman. 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
References
Publications (0)
Data not yet available
No reference posted for this study.