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
Parallel
FOLFIRINOX or gemcitabine-nab-paclitaxel
Drug4 months if treatment
FOLFIRINOX or gemcitabine-nab-paclitaxel
Drug6 months of treatment
Overall survival of all BR/LAPC patients
Comparison of overall survival of all enrolled BR/LAPC patients treated with the standard or the prolonged treatment
Overall survival of all resected BR/LAPC patients
Comparison of overall survival of the resected BR/LAPC patients treated with the standard or the prolonged treatment
Overall survival in intention-to-treat and per protocol treated
Comparison of overall survival of all BR/LAPC patients treated with standard or prolonged treatment in intention-to-treat and in the per protocol treated cohorts
Progression-free survival (PFS) in intention-to-treat and per protocol treated
Comparison of progression-free survival of all BR/LAPC patients treated with standard or prolonged treatment in intention-to-treat and in the per protocol treated cohorts
Overall survival among non-resected BR/LAPC patients
Comparison of overall survival of all non-resected BR/LAPC patients treated with standard or prolonged treatment
Overall and progression-free survival among all and among resected patients with BR in the two arms in ITT
Comparison of overall and progression-free survival of patients with BR treated with standard or prolonged treatment. Comparison in survival will be performed among all enrolled patients and among all resected patients with BR receiving the two treatment durations
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Sahlgrenska University Hospital
Lead sponsor
Karolinska University Hospital
Collaborator
