Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
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.
• 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.
‣ 14\. Signed written informed consent.