drugset / Trial / NCT04167007

FOLFOX vs Gemcitabine in Patients With Metastatic Pancreatic Cancer Non-fit to FOLFIRINOX

NCT04167007 ↗

Phase 3 Unknown 400 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%. The FOLFIRINOX regimen (5-fluorouracil \[5-FU\], folinic acid, irinotecan, and oxaliplatin) and the combination of nab-paclitaxel with gemcitabine demonstrated to be more effective than gemcitabine alone, and are both validated as standard first-line treatment options for metastatic PAC. However, the use of FOLFIRINOX is limited to patients with ECOG performance status (PS) 0-1 and aged less than 75 years. Nab-paclitaxel is currently not reimbursed in France.

Timeline

Start
2020-07-20
Primary completion
2025-07
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous