FOLFIRINEC, A Multi-Center, Randomized, Comparative Phase II Study of FOLFIRINOX vs Platinum-Etoposide as First Line Treatment for Metastatic Neuroendocrine Carcinoma of Gastroenteropancreatic or Unknown Origin, Associated with Molecular Profiling
Introduction: Grade 3 (G3) gastroenteropancreatic (GEP) neuroendocrine carcinoma (NEC) are rare diseases with a poor prognosis. FOLFIRINEC is a multicenter comparative phase II study of mFOLFIRINOX vs platinum-etoposide (PE) as first line treatment for metastatic G3 NEC of GEP or unknown origin.
Aim(s): The main objective is to compare the progression-free survival with mFOLFIRINOX regimen versus PE. The secondary objectives are to evaluate objective response rates according to RECIST 1.1, overall survival, safety and quality of life. A molecular profile with targeted NGS and immunohistochemistry will be performed for all patients with tumor available. Rb expression/mutation, will be studied as a predictive biomarker of response.
Materials and methods: The main inclusion criteria will be: NEC of GEP or unknown origin, metastatic and evaluable disease and no contraindication to chemotherapy. Patients will be randomized 1:1 between PE every 21 days for up to 8 cycles and mFOLFIRINOX every 14 days (5FU 2400 mg/m², irinotecan 180 mg/m², oxaliplatin 85 mg/m²) for up to 12 cycles and stratified according to center, PS, Ki67 and pathological subtype (small vs large cell or undetermined).
Conference: 17th Annual ENETSConcerence (2020)
Presenting Author: Hadoux J
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