Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

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.

NCT Number	NCT06714604
Lead Sponsor	Sahlgrenska University Hospital Collaborators: Karolinska University Hospital
Conditions	Locally Advanced Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Carcinoma, Pancreas Cancer, Neoadjuvant Chemotherapy, Surgery, Pancreatectomy
Enrollment	432 participants
Start Date	2023-10-18
Primary Completion	2032-12-31 (estimated)
Study Completion	2033-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-12-03