Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer.

ABSTRACT:

Aim

To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC).

Methods

This study was a prospective, multicenter, one-arm, open-label, phase II trial. Patients with unresectable PC, who showed disease progression during GEM-based chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin (RIO; irinotecan 120 mg/m² and oxaliplatin 60 mg/m²), which was set according to the phase I study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events were evaluated. Additionally, changes in quality of life (QoL) were assessed u

SUBMITTER: Chung MJ 

PROVIDER: S-EPMC6304301 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature