Comparing Standard and Extended Neoadjuvant Chemotherapy with mFOLFIRINOX or Gemcitabine-Nab-Paclitaxel Before Surgery in Patients with Borderline or Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the best length of neoadjuvant chemotherapy before surgery for patients with borderline and locally advanced pancreatic cancer. This phase III randomized trial compares standard and prolonged durations of two chemotherapy regimens, mFOLFIRINOX and gemcitabine-nab-paclitaxel, to improve survival. Pancreatic cancer often involves critical blood vessels, making surgery challenging, and this study aims to find the optimal chemotherapy length to increase the chance of successful surgery and long-term survival. Participants will be randomly assigned to receive either standard-length chemotherapy6 cycles of mFOLFIRINOX or 4 cycles of gemcitabine-nab-paclitaxelor prolonged chemotherapy12 cycles of mFOLFIRINOX or 6 cycles of gemcitabine-nab-paclitaxelbefore any attempt at surgical removal of the tumor. Treatment continues only if there is no disease progression. The study takes place at national centers specialized in pancreatic surgery, ensuring high-quality care. Throughout the study, patients will undergo regular monitoring to assess tumor response, survival outcomes, surgical complications, and quality of life. Researchers will collect data on overall survival at 24 and 60 months, progression-free survival, resection rates, and biochemical and histopathologic responses. This comprehensive assessment will help determine the best chemotherapy duration to improve outcomes for patients with this challenging form of pancreatic cancer.

Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC