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RecruitingPhase 3NCT04927780

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

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

Sponsor

Erasmus Medical Center

Enrollment

378 participants

Start Date

Sep 7, 2021

Study Type

INTERVENTIONAL

Conditions

Pancreatic CancerPancreatic Ductal AdenocarcinomaResectable Pancreatic Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemotherapy (a drug combination called mFOLFIRINOX) before surgery, after surgery, or both, works better for people with pancreatic cancer that can be removed surgically. **You may be eligible if...** - You have been diagnosed with pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) - Your tumor can be surgically removed (no major involvement of nearby blood vessels) - Your cancer has not spread to other parts of the body - You are 18 years or older and in generally good health - Your blood counts and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have already received radiation, chemotherapy, or surgery for pancreatic cancer - You have had another type of cancer within the last 3 years - You are pregnant or breastfeeding - You have serious other medical conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLeucovorin Calcium

IV

DRUGFluorouracil

IV

DRUGIrinotecan Hydrochloride

IV

DRUGOxaliplatin

IV

PROCEDUREResection

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

View Full Details on ClinicalTrials.gov

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NCT04927780

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