Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.

Inclusion criteria

• Histologically proven rectal adenocarcinoma.
• Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
• Resectable tumor, or considered as potentially resectable after CRT.
• No distant metastases.
• Patient eligible for surgery
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
• 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
• Adequate contraception in fertile patients.
• Adequate hematologic function.

13 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
• Other concomitant cancer.
• Pregnant or breast-feeding woman.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.