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Study Comparing FOLFOX (Oxaliplatin, Fluorouracil, Calcium Folinate) to Gemcitabine for Patients with Metastatic Pancreatic Cancer Not Suitable for FOLFIRINOX

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 is focused on studying a type of cancer called pancreatic adenocarcinoma, which is a cancer that starts in the pancreas. The study is comparing two different treatments for this cancer in patients who have not received prior treatment for their metastatic disease and are not suitable for a more intensive treatment known as FOLFIRINOX. The two treatments being compared are called FOLFOX and gemcitabine. FOLFOX is a combination of three drugs: oxaliplatin, fluorouracil, and calcium folinate. Gemcitabine is a single drug used in this study. The purpose of the study is to see how effective FOLFOX is compared to gemcitabine in treating this type of cancer.

Participants in the study will receive either the FOLFOX treatment or the gemcitabine treatment. Both treatments are given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which the participants will be monitored regularly to assess their response to the treatment. The main goal is to evaluate the overall survival of patients over this period. Additionally, the study will look at other factors such as the response rate to the treatment, the duration of disease control, and any side effects experienced by the participants.

Throughout the study, various assessments will be conducted, including imaging tests like CT scans or MRI to monitor the cancer's progression. Blood tests will also be performed to check levels of certain markers like Ca 19-9 and CEA, which can provide information about the cancer's activity. The study will also evaluate the quality of life of participants using questionnaires. The information gathered from this trial will help determine the best treatment option for patients with pancreatic adenocarcinoma who are not fit for FOLFIRINOX.

The research process

The trial runs in 8 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 asked to provide a signed and dated informed consent. This confirms your willingness and ability to comply with the study requirements.

  2. Step 2

    Initial assessments

    Before starting the treatment, several baseline evaluations will be conducted. These include clinical and blood evaluations, which should be completed no more than 14 days before randomization. Additionally, a tumor assessment using a CT-scan or MRI will be performed within 28 days prior to randomization.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either the FOLFOX treatment or gemcitabine treatment. This is to compare the effectiveness of these treatments for pancreatic adenocarcinoma.

  4. Step 4

    FOLFOX treatment

    If assigned to the FOLFOX group, you will receive a combination of medications: oxaliplatin, fluorouracil, and calcium folinate. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

  5. Step 5

    Gemcitabine treatment

    If assigned to the gemcitabine group, you will receive gemcitabine hydrochloride through an intravenous infusion. This means the medication is given directly into your vein.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

  6. Step 6

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. This includes measuring tumor response, progression-free survival, and overall survival.

    Blood tests will be performed to check levels of specific markers, such as Ca 19-9 and CEA, and to monitor for any side effects or toxicities.

  7. Step 7

    Quality of life evaluation

    Your quality of life will be assessed using questionnaires designed to evaluate health-related quality of life. This helps to understand the impact of the treatment on your daily life and well-being.

  8. Step 8

    End of study

    The study is expected to conclude by January 8, 2027. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

17 criteria

  • Must have signed and dated an informed consent form, showing they understand the study and agree to participate.
  • Must have a confirmed diagnosis of adenocarcinoma of the pancreas through a biopsy or similar test.
  • If a biopsy is not available, there must be strong clinical, biological, and imaging evidence of pancreatic cancer, including a specific type of tumor seen on a CT scan and a blood marker (Ca 19-9) greater than 500 UI/ml.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body (stage IV).
  • Must not have received any prior treatment for metastatic disease. If they had previous treatment for non-metastatic disease, it must have been completed more than 12 months ago.
  • Must be at least 18 years old.
  • Must not be suitable for a specific treatment called FOLFIRINOX and have an ECOG performance status of 0-2, which measures the ability to perform daily activities.
  • If the ECOG performance status is 2, the patient must have an albumin level greater than 25 g/l. Albumin is a protein in the blood.
  • Must have adequate blood cell counts: neutrophils (a type of white blood cell) greater than 2x109/L, platelets greater than 100x109/L, and hemoglobin (a protein in red blood cells) at least 9g/dL.
  • Must have adequate kidney function: serum creatinine level less than 150 μM and estimated creatinine clearance greater than 30 ml/min. Creatinine is a waste product filtered by the kidneys.
  • Must have adequate liver function: AST (SGOT) and ALT (SGPT) levels no more than 2.5 times the upper limit of normal (5 times if there are liver metastases).
  • Total bilirubin level must be no more than 3 times the upper limit of normal. Bilirubin is a substance made during the breakdown of red blood cells.
  • The QT/QTc interval on an ECG (a heart test) must be less than 450 msec for men and less than 470 msec for women. This measures the heart's electrical activity.
  • All necessary evaluations, including clinical and blood tests, must be done no more than 2 weeks before starting the study, and tumor assessments must be done no more than 28 days before starting.
  • Female patients must be surgically sterile, postmenopausal, or agree to use reliable contraception during the study and for at least six months after. They must have a negative pregnancy test before starting the study. Breastfeeding is not allowed.
  • Male patients must agree to use effective contraception and ensure their partner also uses contraception during the study and for at least six months after.
  • Must be affiliated with a French social security system.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides pancreatic adenocarcinoma cannot participate. Pancreatic adenocarcinoma is a type of cancer that starts in the pancreas.
  • Patients who have already received treatment for their cancer with a regimen called FOLFIRINOX are not eligible. FOLFIRINOX is a combination of drugs used to treat pancreatic cancer.
  • Patients who are considered fit for FOLFIRINOX treatment cannot join the study. Being "fit" means being healthy enough to handle the side effects of this strong treatment.
  • Patients who are not able to understand or follow the study procedures are excluded.
  • Patients with serious medical conditions that could interfere with the study are not allowed to participate.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are participating in another clinical trial at the same time are not eligible.
  • Patients with known allergies to the study drugs or their ingredients cannot join.
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Investigated drugs

  • FOLFOX

    is a combination of chemotherapy drugs used to treat certain types of cancer, including pancreatic cancer. It includes a mix of drugs that work together to stop cancer cells from growing and spreading. This treatment is often used when other treatments might not be suitable for the patient.

  • Gemcitabine

    is a chemotherapy drug that is used to treat various types of cancer, including pancreatic cancer. It works by slowing or stopping the growth of cancer cells. This medication is often used when the cancer is advanced or has spread to other parts of the body.

What is already known about the treatment

  • FOLFOX

    FOLFOX is a combination chemotherapy regimen administered intravenously, typically used to treat certain types of cancer, including pancreatic adenocarcinoma. It is currently being studied in clinical trials to evaluate its effectiveness compared to gemcitabine for patients with metastatic pancreatic cancer who are not suitable for FOLFIRINOX treatment. The main therapeutic indication for FOLFOX in this trial is pancreatic adenocarcinoma. At the molecular level, FOLFOX works by interfering with the DNA replication process in cancer cells, which prevents them from growing and dividing. It is classified pharmacologically as a chemotherapy regimen.

  • Gemcitabine

    Gemcitabine is a chemotherapy medication administered intravenously, commonly used to treat various types of cancer, including pancreatic adenocarcinoma. In the current clinical trial, it is being compared to the FOLFOX regimen to determine its efficacy as a first-line treatment for patients with metastatic pancreatic cancer who are not fit for FOLFIRINOX. The main therapeutic indication for gemcitabine in this context is pancreatic adenocarcinoma. Gemcitabine works at the molecular level by incorporating itself into the DNA of cancer cells, thereby inhibiting their ability to replicate. It is classified pharmacologically as an antimetabolite chemotherapy agent.

Investigated diseases

Pancreatic adenocarcinoma – Pancreatic adenocarcinoma is a type of cancer that originates in the tissues of the pancreas, specifically in the cells that line the ducts of the pancreas. It is characterized by the uncontrolled growth of abnormal cells in the pancreas, which can form a tumor. As the disease progresses, the tumor may invade nearby tissues and organs, such as the stomach, liver, and intestines. The cancer cells can also spread to distant parts of the body through the bloodstream or lymphatic system, a process known as metastasis. Symptoms often develop gradually and may include abdominal pain, weight loss, jaundice, and digestive problems. The progression of the disease can vary, but it typically involves increasing severity of symptoms and potential complications as the cancer advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511904-18-00Protocol codeD20180177Estimated enrolment400 patientsSponsorAssistance Publique Hopitaux De Paris

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