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Study on Chemotherapy for Patients with Resected Pancreatic Cancer Using FOLFIRINOX and Drug Combination

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What is this trial about?

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

This clinical trial is focused on studying treatments for pancreatic adenocarcinoma, a type of cancer that begins in the tissues of the pancreas. The study aims to evaluate the effectiveness of different chemotherapy treatments after surgery for patients who have already received a specific type of chemotherapy called FOLFIRINOX before their surgery. The main goal is to see how these treatments affect the time patients remain free from cancer and their overall survival.

Participants in the study will receive one of two types of chemotherapy. One group will receive a treatment guided by the analysis of their tumor after surgery, while the other group will receive a standard treatment called mFOLFIRINOX, regardless of the tumor analysis. The medications used in this study include Levoleucovorin (also known as Elvorine), Paclitaxel (known as Apexelsin), Gemcitabine, Irinotecan, Fluorouracil, and Oxaliplatin. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The study will take place over several months, with participants receiving treatment in cycles. The effects of the treatments will be monitored to determine their impact on the patients' health and quality of life. Some participants may receive a placebo as part of the study. The trial will help researchers understand which treatment approach is more effective for patients with resected pancreatic adenocarcinoma following neoadjuvant chemotherapy.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of being placed in either group.

  2. Step 2

    Treatment group assignment

    If you are placed in Arm A, your treatment will be guided by the analysis of your tumor after surgery. This means the treatment will be adjusted based on the characteristics of your tumor.

    If you are placed in Arm B, you will receive a standard treatment called mFOLFIRINOX, which is a combination of medications used to treat pancreatic cancer, regardless of the tumor analysis.

  3. Step 3

    Medication administration

    The medications used in this study include levoleucovorin, paclitaxel, gemcitabine, irinotecan, fluorouracil, and oxaliplatin. These are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

    The specific dosage, frequency, and duration of each medication will depend on the treatment plan you are assigned to. Your healthcare team will provide detailed instructions and monitor your progress throughout the treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess how well the treatment is working and to check for any side effects.

    You will also be asked to complete questionnaires about your quality of life and any symptoms you may experience. This information helps to understand the impact of the treatment on your daily life.

  5. Step 5

    End of treatment

    After completing the treatment phase, you will continue to be monitored for a period of time to assess your overall health and any long-term effects of the treatment.

    The study aims to evaluate the effectiveness of the treatment in terms of disease-free survival and overall survival. This means looking at how long you remain free of cancer and your overall lifespan after treatment.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of resected pancreatic adenocarcinoma, which means the cancer has been surgically removed. This includes tumors that were either clearly removable or borderline removable.
  • Must have received 3 months of a specific chemotherapy treatment called neoadjuvant mFOLFIRINOX before surgery.
  • Must have a performance status of ECOG 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must have a CA 19-9 level of 200 U/ml or less. CA 19-9 is a substance in the blood that can be a marker for pancreatic cancer.
  • Must be aged 18 or older.
  • Must have certain blood test results:
    • Absolute neutrophil count greater than 1,500 mm3
    • Platelet count greater than 100,000 mm3
    • Creatinine clearance greater than 50 ml/min, which measures kidney function
    • Hemoglobin level greater than 10 g/dl, which measures red blood cells (transfusions are allowed)
    • Women who can have children must use highly effective contraception during the study and for 15 months after treatment ends. They must also have a negative pregnancy test before starting the study and regularly during the study.
    • Men must use contraception during the study and for 12 months after stopping treatment.
    • Must be part of a social security or national health insurance plan.
    • Must be able to follow the study rules, as judged by the study doctor.
    • Must have read and understood the information about the study and signed the consent form.

Who cannot join the trial?

10 criteria

  • Patients who have not had their pancreatic cancer surgically removed cannot participate.
  • Patients who have not completed 6 cycles of a specific pre-surgery chemotherapy called modified FOLFIRINOX cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or attend follow-up visits cannot participate.
  • Patients with other serious health conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have had another type of cancer within the last 5 years cannot participate, except for certain skin cancers or in situ cervical cancer.
  • Patients with known allergies to the study drugs cannot participate.
  • Patients with a history of severe allergic reactions cannot participate.
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Investigated drugs

  • FOLFIRINOX

    is a combination of four different chemotherapy drugs used to treat pancreatic cancer. It includes a mix of medications that work together to stop cancer cells from growing and spreading. This treatment is often used before surgery to shrink the tumor and make it easier to remove.

  • mFOLFIRINOX

    is a modified version of the FOLFIRINOX treatment. It is adjusted to be less intense, which can help reduce side effects while still aiming to prevent the cancer from coming back after surgery. This treatment is used after the tumor has been surgically removed to help ensure that any remaining cancer cells are destroyed.

What is already known about the treatment

FOLFIRINOX – FOLFIRINOX is a combination chemotherapy regimen administered intravenously, meaning it is given through a vein. It is currently used in the treatment of pancreatic cancer, specifically for patients who have undergone surgery to remove the cancer. The main purpose of FOLFIRINOX is to help prevent the cancer from returning by targeting and killing any remaining cancer cells. At the molecular level, it works by interfering with the DNA and RNA of cancer cells, preventing them from growing and dividing. FOLFIRINOX is classified as an antineoplastic or anticancer treatment.

Investigated diseases

Pancreatic Adenocarcinoma – Pancreatic adenocarcinoma is a type of cancer that originates in the tissues of the pancreas, specifically in the ducts that carry digestive enzymes. It typically begins as a small lesion in the pancreatic duct and can grow to invade nearby tissues and organs. As the disease progresses, it may spread to lymph nodes and distant organs such as the liver and lungs. The progression of pancreatic adenocarcinoma is often aggressive, with the potential for rapid growth and spread. Symptoms may include abdominal pain, weight loss, jaundice, and changes in stool. Early stages may not present noticeable symptoms, making it challenging to detect until it has advanced.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519048-33-00Protocol code2021/0377/HPEstimated enrolment390 patientsSponsorCentre Hospitalier Universitaire Rouen

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).