Status:
COMPLETED
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
Lead Sponsor:
UNICANCER
Conditions:
Cancer of the Rectum
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 preo...
Detailed Description
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 imme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT01804790
Start Date
January 1 2012
End Date
July 1 2023
Last Update
June 12 2025
Active Locations (36)
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1
Centre hospitalier Universitaire d'Amiens
Amiens, France
2
ICO - Site Paul Papin
Angers, France
3
Centre hospitalier d'Auxerre
Auxerre, France
4
Centre Hospitalier de Beauvais
Beauvais, France