Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Last updated: August 27, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Pancreatic Cancer

Pancreatic Disorders

Treatment

Irinotecan Hydrochloride

Leucovorin Calcium

Oxaliplatin

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: Irinotecan Hydrochloride
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

    Active - Recruiting

  • Meander Medical Center

    Amersfoort,
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Amphia Hospital

    Breda,
    Netherlands

    Active - Recruiting

  • Deventer Hospital

    Deventer,
    Netherlands

    Active - Recruiting

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Tjongerschans Hospital

    Heerenveen,
    Netherlands

    Active - Recruiting

  • Medical Center Leeuwarden

    Leeuwarden,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus MC University Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Regional Academic Center Utrecht, Antonius Hospital

    Utrecht,
    Netherlands

    Active - Recruiting

  • Isala Hospital

    Zwolle,
    Netherlands

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Skåne University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

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