Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Capecitabine; Leucovorin

Criteria

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.