NCT04927780

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Leucovorin Calcium	IV
DRUG	Fluorouracil	IV
DRUG	Irinotecan Hydrochloride	IV
DRUG	Oxaliplatin	IV
PROCEDURE	Resection	Open or minimally-invasive pancreatectomy.

Timeline

• Start date: 2021-09-07
• Primary completion: 2026-02-01
• Completion: 2029-07-01
• First posted: 2021-06-16
• Last updated: 2024-08-28

Locations

22 sites across 3 countries: Netherlands, Norway, Sweden

Regulatory

• FDA-regulated drug study