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Study comparing FOLFIRINOX versus gemcitabine-based chemoradiotherapy in patients with resectable or borderline 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 clinical trial focuses on patients with pancreatic cancer that is (borderline) resectable and has not spread to other parts of the body. The study compares two different treatment approaches for this type of cancer. The first treatment approach uses a combination of medications called FOLFIRINOX, which includes fluorouracil, folinic acid, irinotecan, and oxaliplatin. The second treatment approach uses gemcitabine combined with radiation therapy.

The purpose of this study is to determine if giving FOLFIRINOX before surgery leads to better survival rates and quality of life compared to giving chemotherapy with radiation before surgery followed by gemcitabine after surgery. Both treatments are given through an infusion, which means the medications are delivered directly into the bloodstream through a vein.

The treatment plan involves receiving either FOLFIRINOX or gemcitabine with radiation therapy before surgery. After surgery, patients in the second group will receive additional treatment with gemcitabine. The total treatment period may last up to 44 weeks, depending on which treatment group the patient is assigned to.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis confirmation

    A histological or cytological confirmation of pancreatic cancer will be performed

    Medical evaluation will confirm your eligibility based on specific health criteria, including blood tests showing adequate levels of white blood cells, platelets, and hemoglobin

    Your kidney function will be assessed through an E-GFR test which must be above 50 ml/min

  2. Step 2

    Treatment path assignment

    You will be assigned to one of two treatment paths:

    Path 1: FOLFIRINOX treatment before surgery

    Path 2: Chemotherapy combined with radiation therapy before surgery, followed by additional treatment after surgery

  3. Step 3

    Pre-surgery treatment - Path 1

    If assigned to Path 1, you will receive FOLFIRINOX, which includes:

    - Irinotecan through infusion

    - Folinic acid through infusion

    - Oxaliplatin through infusion

    - Fluorouracil through infusion

  4. Step 4

    Pre-surgery treatment - Path 2

    If assigned to Path 2, you will receive:

    Gemcitabine through infusion combined with radiation therapy

  5. Step 5

    Surgery

    After completing the pre-surgery treatment, a surgical procedure will be performed to remove the tumor

  6. Step 6

    Post-surgery treatment - Path 2

    If you were assigned to Path 2, you will receive additional gemcitabine treatment through infusion after surgery

  7. Step 7

    Follow-up period

    Regular check-ups will be conducted to monitor your progress

    The study will continue until June 2026

Who can join the trial?

10 criteria

  • You must have confirmed pancreatic cancer through tissue or cell examination
  • You must provide written informed consent to participate in the study
  • Your cancer must be (borderline) resectable (possible to remove with surgery) and must not have spread to other parts of the body
  • Your physical performance status must be good (able to carry out all normal activity or only restricted in physically strenuous activity)
  • You must be healthy enough to undergo surgery, chemotherapy and radiation therapy
  • Your white blood cell count must be at least 3.0 X 109/l
  • Your blood platelet count must be at least 100 X 109/l
  • Your hemoglobin level (oxygen-carrying protein in blood) must be at least 6 mmol/l
  • Your kidney function must be adequate (filtration rate above 50 ml/min)
  • You must be 18 years or older

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 75 years
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Previous treatment with chemotherapy (medications used to kill cancer cells) or radiation therapy for pancreatic cancer
  • Pregnant or breastfeeding women
  • Severe heart conditions or recent heart attack (within last 6 months)
  • Severe kidney problems (creatinine clearance less than 50 mL/min)
  • Severe liver problems
  • Active, uncontrolled infections
  • Known allergies to any of the study medications
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that could interfere with following study procedures
  • Any other serious medical condition that could affect participation in the study
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Investigated drugs

FOLFIRINOX is a combination chemotherapy treatment that contains multiple medications working together to fight pancreatic cancer. It is used before surgery (neoadjuvant therapy) to help shrink the tumor and improve surgical outcomes. Gemcitabine is a chemotherapy medication used in combination with radiation therapy (chemoradiotherapy) before surgery, and also given alone after surgery (adjuvant therapy). It works by interfering with cancer cell growth and division. Radiation therapy is a treatment that uses high-energy beams to target and destroy cancer cells. In this trial, it is combined with gemcitabine before surgery as part of the chemoradiotherapy approach.

What is already known about the treatment

  • FOLFIRINOX

    A combination chemotherapy regimen administered intravenously that consists of four drugs (fluorouracil, leucovorin, irinotecan, and oxaliplatin). It is used as a neoadjuvant treatment for non-metastatic borderline resectable pancreatic cancer before surgery. The medication works by targeting rapidly dividing cancer cells through multiple mechanisms, including DNA damage and interference with cell division. This treatment is classified as a multi-agent cytotoxic chemotherapy protocol and represents one of the most aggressive standard treatment options in pancreatic cancer therapy.

  • Gemcitabine

    An intravenously administered chemotherapy medication that belongs to the antimetabolite class of drugs. It is commonly used both as part of neoadjuvant chemoradiotherapy and as adjuvant therapy after surgery in patients with borderline resectable pancreatic cancer. The drug works by interfering with DNA synthesis in cancer cells, preventing them from dividing and growing. Gemcitabine has become a standard treatment option in pancreatic cancer due to its established efficacy and manageable side effect profile.

Investigated diseases

Pancreatic Cancer - A condition that begins when abnormal cells start growing in the pancreas, forming a tumor. The disease typically develops in the exocrine cells of the pancreas, which are responsible for producing digestive enzymes. In non-metastatic cases, the cancer remains localized to the pancreas and nearby tissues, without spreading to distant parts of the body. Borderline resectable pancreatic cancer refers to tumors that are at the edge of being surgically removable, involving nearby blood vessels to a limited extent. The disease can affect the body's ability to produce digestive enzymes and regulate blood sugar levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516260-29-00Estimated enrolment368 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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