FOLFIRINOX or FOLFOX for locally advanced or metastatic small bowel adenocarcinoma: PRODIGE 86 – FFCD-GONO – ENGIC 02 – FOLFIRINOX SBA phase II randomized trial

Background: Small bowel adenocarcinoma (SBA) is rare. Palliative chemotherapy was evaluated mainly in retrospective studies. No randomized trial has been previously performed to evaluate front line chemotherapy in advanced SBA. Methods: Randomized, non-comparative, open-label, multi-center phase II study to evaluate mFOLFOX (D1=D15: oxaliplatin 85 mg/m2, folinic acid: 400 mg/m2, 5FU bolus: 400 mg/m2 followed by 5FU: 2400 mg/m2 IV infusion over 46 h) and mFOLFIRINOX (mFOLFOX plus irinotecan 180 mg/m2, without 5FU bolus) in the first line treatment of unresectable locally advanced or metastatic SBA. Ampullary carcinoma and MSI-H/dMMR SBA are excluded. The primary endpoint is to assess the percentage of patients alive without progression at 8 months. In each arm, assuming a null hypothesis of 40 % of patients free of progression at 8 months, and a target percentage of 55 %, 65 patients per arm are needed with 85 % power and 10 % one-sided type I error. Randomizations started in February 2024.