Studying How Tumor Types Affect Response to FOLFIRINOX Chemotherapy Before Surgery in Adults With Non-Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are studying how the genetic makeup of pancreatic ductal adenocarcinoma PDAC, a type of pancreatic cancer, affects the response to the chemotherapy treatment FOLFIRINOX given before surgery. This research focuses on patients with PDAC that can be surgically removed or is locally advanced but not spread to distant sites. The study aims to understand if pre-surgery FOLFIRINOX improves the ability to remove tumors and reduces cancer recurrence by examining changes in tumor genetics before and after treatment. Participants will receive FOLFIRINOX chemotherapy every two weeks as outpatients for up to 12 cycles 24 weeks or until disease progression or unacceptable side effects. After 8 cycles, imaging will assess if surgery is possible if so, surgery occurs followed by 4 more cycles of chemotherapy. The drugs include oxaliplatin, leucovorin, irinotecan, and 5-FU, with 5-FU delivered partly by a continuous infusion pump over 46 hours. Biopsies and blood samples will be collected before treatment and after 8 cycles to study molecular changes in tumor and stromal subtypes. During the study, participants undergo regular imaging every 8 weeks to monitor tumor response and resectability. Researchers will evaluate response rates, resectability, survival, adverse events, and changes in tumor subtype over up to 3 years of follow-up. Participants must have adequate organ function and performance status and will be monitored for safety and treatment effects throughout the study and follow-up period.

Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer