Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Last updated: May 13, 2026
Sponsor: Erasmus Medical Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Pancreatic Disorders

Digestive System Neoplasms

Cancer

Treatment

Resection

Irinotecan Hydrochloride

Leucovorin Calcium

Clinical Study ID

NCT04927780
MEC-2021-0002
2020-005141-16
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductaladenocarcinoma.

  • Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterialcontact and venous contact with the superior mesenteric vein or portal vein of 90degrees or less

  • No evidence for metastatic disease

  • WHO performance status of 0 or 1

  • Ability to undergo surgery and mFOLFIRINOX chemotherapy

  • Leucocytes (WBC) ≥ 3.0 x 10^9/L

  • Platelets ≥ 100 x 10^9/L

  • Hemoglobin ≥ 6.0 mmol/l

  • Renal function: eGFR ≥ 40 ml/min

  • Age ≥ 18 years

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.

  • Prior chemotherapy precluding mFOLFIRINOX.

  • Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrinetumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless noevidence of disease and diagnosed more than 3 years before diagnosis of pancreaticcancer, or with a life expectancy of more than 5 years from date of inclusion.

  • Pregnancy or lactation.

  • Serious concomitant systemic disorders that would compromise the safety of thepatient or his/her ability to complete the study, at the discretion of theinvestigator.

Study Design

Total Participants: 378
Treatment Group(s): 5
Primary Treatment: Resection
Phase: 3
Study Start date:
September 07, 2021
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Jeroen Bosch Hospital

    's-Hertogenbosch,
    Netherlands

    Site Not Available

  • Meander Medical Center

    Amersfoort,
    Netherlands

    Site Not Available

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Site Not Available

  • OLVG

    Amsterdam,
    Netherlands

    Site Not Available

  • Amphia Hospital

    Breda,
    Netherlands

    Site Not Available

  • Deventer Hospital

    Deventer,
    Netherlands

    Site Not Available

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Site Not Available

  • Tjongerschans Hospital

    Heerenveen,
    Netherlands

    Site Not Available

  • Medical Center Leeuwarden

    Leeuwarden,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus MC University Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Site Not Available

  • Regional Academic Center Utrecht, Antonius Hospital

    Utrecht,
    Netherlands

    Site Not Available

  • Isala Hospital

    Zwolle,
    Netherlands

    Site Not Available

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

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