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Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

NCT04927780 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2026-05-15

No results posted yet for this study

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

Interventions

DRUG

Leucovorin Calcium

IV

DRUG

Fluorouracil

IV

DRUG

Irinotecan Hydrochloride

IV

DRUG

Oxaliplatin

IV

PROCEDURE

Resection

Open or minimally-invasive pancreatectomy.

Sponsors & Collaborators

  • Dutch Pancreatic Cancer Group

    collaborator UNKNOWN

  • Dutch Cancer Society

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Bas Groot Koerkamp, MD, PhD · Erasmus MC University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2027-01-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927780 on ClinicalTrials.gov