Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2025
FOLFIRINOX or FOLFOX for locally advanced or metastatic small bowel adenocarcinoma: PRODIGE 86 - FFCD-GONO - ENGIC 02 - FOLFIRINOX SBA phase II randomized trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Aparicio Thomas, Turpin Anthony, Zaanan Aziz, de la Fouchardière Christelle, Le Malicot Karine, Lonardi Sara, Modest Dominik Paul, Wilson Richard, Cremolini Chiara, Ballhausen Alexej, Graham Janet, Kurreck Annika, Guarssifi Meriem, Svrcek Magali, Laurent-Puig Pierre, Manfredi Sylvain
Аннотация
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.
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.