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Study of perioperative versus post-surgery FOLFIRINOX (irinotecan, oxaliplatin, fluorouracil, and folinic acid) treatment in patients with resectable pancreatic cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with resectable pancreatic cancer that has not spread to other parts of the body. The treatment being studied is a combination chemotherapy known as FOLFIRINOX, which consists of four medications: fluorouracil, folinic acid, irinotecan, and oxaliplatin. These medications are given through an infusion into a vein.

The purpose of this research is to determine if giving FOLFIRINOX treatment both before and after surgery (perioperative) leads to better survival outcomes compared to giving it only after surgery (adjuvant). The study will compare these two different approaches to treatment timing in patients who can have their pancreatic cancer surgically removed.

During the study, patients will receive the same combination of medications but at different times in relation to their surgery. The treatment will continue for several weeks, with regular medical check-ups to monitor the patient's condition. The medications work together to stop cancer cells from growing and dividing, with each drug playing a specific role in fighting the cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment group assignment

    You will be assigned to one of two treatment groups: perioperative or adjuvant treatment with modified FOLFIRINOX chemotherapy.

  2. Step 2

    Perioperative group treatment path

    If assigned to the perioperative group, you will receive chemotherapy both before and after surgery

    The treatment consists of modified FOLFIRINOX, which includes four medications given through infusion:

    - Irinotecan

    - Oxaliplatin

    - Folinic acid

    - Fluorouracil

  3. Step 3

    Adjuvant group treatment path

    If assigned to the adjuvant group, you will receive surgery first

    After recovery from surgery, you will receive the same chemotherapy combination (modified FOLFIRINOX)

    The treatment includes the same four medications given through infusion

  4. Step 4

    Surgery

    Surgery will be performed to remove the pancreatic cancer

    The timing of surgery depends on your assigned treatment group

  5. Step 5

    Follow-up period

    Your health status will be monitored throughout the study period

    The study continues until February 2026

Who can join the trial?

10 criteria

  • You must have a confirmed diagnosis of pancreatic ductal cancer through tissue examination or cell testing
  • You must be 18 years or older
  • Your tumor must be removable by surgery, with specific characteristics: no contact with arteries and limited contact with certain blood vessels (superior mesenteric vein or portal vein)
  • Your cancer must not have spread to other parts of the body
  • You must have good physical functioning ability (WHO performance status of 0 or 1, meaning you can perform all or most daily activities)
  • You must be healthy enough to undergo both surgery and chemotherapy treatment
  • Your blood test results must show:
    • White blood cells of 3.0 X 109/L or higher
    • Platelets of 100 X 109/L or higher
    • Hemoglobin level of 6.0 mmol/l or higher
    • Your kidney function (eGFR) must be 40 ml/min or higher

Who cannot join the trial?

15 criteria

  • Previous treatment with chemotherapy or radiation therapy for pancreatic cancer
  • Known metastatic disease (cancer that has spread to other parts of the body)
  • Presence of other active cancers in the past 5 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Severe heart conditions including:
    • Heart attack within past 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
    • Severe liver problems (as shown in blood tests)
    • Severe kidney problems (as shown in blood tests)
    • Active, uncontrolled infections
    • Known allergies to any of the study medications
    • Pregnancy or breastfeeding
    • Inability to understand or sign informed consent
    • Participation in another clinical trial within the past 30 days
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
    • Mental health conditions that could interfere with study participation
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Investigated drugs

FOLFIRINOX is a combination chemotherapy treatment that includes several medications working together to fight pancreatic cancer. It combines three chemotherapy drugs: fluorouracil (5-FU), irinotecan, and oxaliplatin, along with leucovorin (also known as folinic acid) which helps the other medications work better. This treatment is used either before and after surgery (perioperative) or only after surgery (adjuvant) for patients with pancreatic cancer that can be removed by surgery. The medications in FOLFIRINOX work in different ways: fluorouracil stops cancer cells from making new DNA, irinotecan prevents cancer cells from dividing and growing, and oxaliplatin damages the DNA in cancer cells. When used together, these medications can be more effective at treating pancreatic cancer than when used alone.

What is already known about the treatment

FOLFIRINOX - A combination chemotherapy regimen administered intravenously that consists of four drugs (FOL - folinic acid/leucovorin, F - fluorouracil, IRIN - irinotecan, and OX - oxaliplatin). This treatment is primarily used in pancreatic cancer therapy, particularly in resectable pancreatic cancer cases before and after surgery (perioperative treatment). The medication works by targeting rapidly dividing cancer cells through multiple mechanisms: interfering with DNA synthesis, inhibiting topoisomerase I enzyme, and disrupting cancer cell division. FOLFIRINOX belongs to the class of combination chemotherapy agents and represents one of the most effective treatment options for pancreatic cancer, though it may cause more side effects compared to single-agent chemotherapy treatments.

Investigated diseases

Pancreatic Cancer - A condition that develops when abnormal cells begin growing in the pancreas, forming tumors that affect the organ's ability to function normally. The disease typically starts in the cells that line the ducts of the pancreas, which are responsible for carrying digestive enzymes. As the cancer grows, it can interfere with the pancreas's ability to produce important digestive enzymes and hormones that help regulate blood sugar. The cancer may begin to affect nearby structures and organs in the abdomen. In its resectable form, the tumor is confined to the pancreas or immediate surrounding area and can be surgically removed. Non-metastatic pancreatic cancer means the disease has not spread to distant parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510617-15-00Estimated enrolment378 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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