Randomized phase 2 trial of nab-paclitaxel plus gemcitabine, ± capecitabine, cisplatin (PAXG regimen) in unresectable or borderline resectable pancreatic adenocarcinoma

Abstract

Methods: Chemo-naive patients with 18-75 years, pathologic diagnosis of unresectable or borderline resectable pancreatic adenocarcinoma (NCCN definition), Karnofsky Performance Status ≥ 70 were eligible for the study. The primary endpoint was resectability rate. According to A' Hern design (p0 = 5%; p1 = 20%; α = 0.05; power = 80%), the total number of patients to enrol in each arm was 27. With ≥ 4 of 27 eligible patients resected, each regimen will be considered active.