Comparing mFOLFIRINOX and Platinum-Etoposide Chemotherapy for Metastatic Grade 3 Poorly Differentiated Neuroendocrine Carcinoma of Gastro-Entero-Pancreatic and Unknown Origin with Molecular Biomarker Analysis

What this Trial Is About

Researchers are investigating improved chemotherapy options for patients with metastatic Grade 3 poorly differentiated neuroendocrine carcinomas G3 NEC of the gastro-entero-pancreatic GEP system or unknown origin. These cancers are rare, often diagnosed at an advanced stage, and have limited treatment success with the current standard platinum-etoposide chemotherapy. The study aims to compare the mFOLFIRINOX regimen to the standard platinum-etoposide treatment and to explore molecular characteristics that might predict which patients respond best to each therapy. The trial compares two chemotherapy regimens mFOLFIRINOX, given every 14 days for up to 12 cycles, and platinum-etoposide, administered every 21 days for 6 to 8 cycles or up to 24 weeks. Both treatments are given intravenously on day 1 of each cycle, with continuation depending on disease progression and side effects. The mFOLFIRINOX regimen combines 5-fluorouracil, oxaliplatin, and irinotecan, while the platinum-etoposide regimen includes cisplatin or carboplatin plus etoposide. Molecular profiling of tumors will also be performed to identify biomarkers that may guide therapy choices. Participants will undergo regular scans and laboratory tests to monitor tumor response and side effects. Researchers will measure progression-free survival as the main outcome, along with overall survival, response rates, and treatment tolerability over up to 24 months. The study involves random assignment to one of the two treatment groups and requires ongoing monitoring to assess how well the therapies work and their safety in this patient population.

Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary