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RECRUITING
NCT04927780
PHASE3

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

378

Start Date

2021-09-07

Completion Date

2029-07

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DRUG

Leucovorin Calcium

IV

DRUG

Fluorouracil

IV

DRUG

Irinotecan Hydrochloride

IV

DRUG

Oxaliplatin

IV

PROCEDURE

Resection

Open or minimally-invasive pancreatectomy.

Locations (22)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Meander Medical Center

Amersfoort, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Amphia Hospital

Breda, Netherlands

Deventer Hospital

Deventer, Netherlands

Catharina Hospital

Eindhoven, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Tjongerschans Hospital

Heerenveen, Netherlands

Medical Center Leeuwarden

Leeuwarden, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus MC University Medical Center

Rotterdam, Netherlands

Maasstad Ziekenhuis

Rotterdam, Netherlands

Regional Academic Center Utrecht, Antonius Hospital

Utrecht, Netherlands

Isala Hospital

Zwolle, Netherlands

Oslo University Hospital

Oslo, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden