Comparing Chemotherapy Before Surgery Versus Immediate Surgery for Treatable Pancreatic Head and Periampullary Cancer to Improve Survival

What this Trial Is About

This research aims to compare two treatment approaches for patients with clearly resectable pancreatic head cancer and periampullary cancer. It investigates whether receiving chemotherapy before surgery neoadjuvant chemotherapy improves overall survival compared to having surgery first followed by chemotherapy. The study addresses the challenge that only about half of patients start chemotherapy after surgery and explores whether pre-surgery treatment can better control hidden cancer spread and improve surgical outcomes. Participants will be randomly assigned to one of two groups one group will receive neoadjuvant chemotherapy using the mFOLFIRINOX regimen followed by pancreaticoduodenectomy surgery, while the other group will undergo upfront laparoscopic pancreaticoduodenectomy followed by adjuvant chemotherapy. The trial includes monitoring of resection rates, chemotherapy completion, and surgical complications. Both treatment strategies are closely evaluated over several months. During the study, participants will be regularly assessed through imaging and laboratory tests to evaluate overall survival up to three years. Secondary measurements include disease-free survival, recurrence rates, response to chemotherapy, and surgical outcomes such as margin status. Researchers will also track perioperative complications and biomarker changes during chemotherapy. The study duration includes follow-up for up to three years to monitor long-term outcomes and treatment effects.

Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer