The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR/LAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR/LAPC.
Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022
Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
T1-4, Nx, M0 according to AJCC 8th edition
ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR/LAPC
Co-morbidity precluding pancreatic surgery or chemotherapy
Contraindications to any of the drugs in the proposed treatment regimens
ECOG ≥2
Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6
Sahlgrenska University Hospital
Lead sponsor
Karolinska University Hospital
Collaborator