drugset / Trial / NCT04325425

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

NCT04325425 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in order to try to answer these questions

Timeline

Start
2020-09-01
Primary completion
2029-09
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule — Intravenous
Comparator Cisplatin Other / unclassified 100 mg/m2 Intravenous
Comparator Etoposide Small molecule 100 mg/m2 Intravenous
Subject Irinotecan Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject fluorouracil Small molecule — —