drugset / Trial / NCT04927780

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

NCT04927780 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Timeline

Start
2021-09-07
Primary completion
2027-01
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 150 mg/m2 —
Subject Leucovorin Small molecule 400 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2.4 g Intravenous