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Study Comparing mFOLFIRINOX and Capecitabine or Gemcitabine for Patients with Resected Ampullary Adenocarcinoma

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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 ampullary adenocarcinoma, which occurs in the area where the bile duct and pancreatic duct meet the small intestine. The study is investigating the effectiveness of different chemotherapy treatments in patients who have had this cancer surgically removed. The treatments being studied include a combination therapy known as modified FOLFIRINOX, which includes the drugs oxaliplatin, irinotecan, fluorouracil, and calcium folinate, compared to single-agent therapies using either capecitabine or gemcitabine. These medications are used to help prevent the cancer from returning after surgery.

The purpose of the study is to determine which treatment is more effective in improving the chances of staying cancer-free for two years after surgery. Participants in the study will be randomly assigned to receive either the modified FOLFIRINOX combination or one of the single-agent therapies. The study will last for up to 24 months, during which time participants will receive their assigned treatment and be monitored for any signs of cancer recurrence. Some participants may receive a placebo as part of the study design.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study will also assess the overall survival rate, which is the time from the start of the study until death from any cause, and the quality of life of participants using specific questionnaires. The trial aims to provide valuable information on the best treatment approach for patients with resected ampullary adenocarcinoma, potentially improving outcomes and quality of life for those affected by this condition.

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, eligibility is confirmed based on specific criteria such as age, surgical history, and health status.

    The study focuses on patients with a type of cancer called ampullary adenocarcinoma that has been surgically removed.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving a combination of drugs known as mFOLFIRINOX, and the other receiving either capecitabine or gemcitabine.

  3. Step 3

    Treatment phase

    The mFOLFIRINOX group receives a combination of drugs including oxaliplatin, calcium folinate, fluorouracil, and irinotecan, administered intravenously.

    The capecitabine group takes the medication orally in the form of film-coated tablets.

    The gemcitabine group receives the drug intravenously.

    Treatment duration and dosage are determined by the study protocol, with regular monitoring to ensure safety and effectiveness.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular health assessments to monitor the effects of the treatment.

    The primary goal is to evaluate the disease-free survival rate over two years, meaning the time during which the cancer does not return.

    Secondary assessments include overall survival, treatment completion rates, and quality of life evaluations using specific questionnaires.

  5. Step 5

    Completion of the study

    The study is expected to conclude by October 31, 2028.

    Final results will be analyzed to determine the effectiveness of the treatments in preventing cancer recurrence and improving survival rates.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **ampullary adenocarcinoma**. This means that the cancer originates in the ampulla of Vater, an area where the bile duct and pancreatic duct meet.
  • The patient must have had a **surgical resection** of the ampullary adenocarcinoma. This means the cancer was surgically removed, and the surgery was considered complete.
  • The cancer must have been removed within the last 12 weeks before joining the study.
  • The patient must not have **metastatic disease**. This means the cancer has not spread to other parts of the body, as shown by a CT scan done within 4 weeks before joining the study.
  • The patient's **CA19.9 level** must be less than 180 U/L at the time of joining the study. CA19.9 is a substance in the blood that can be higher in some cancer patients.
  • The patient must be 18 years of age or older.

Who cannot join the trial?

8 criteria

  • Patients who have not had surgery to remove the ampullary adenocarcinoma cannot participate.
  • Patients who are unable to take the study medications, such as mFOLFIRINOX, gemcitabine, or capecitabine, are excluded.
  • Patients with other serious health conditions that could interfere with the study treatment are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are participating in another clinical trial at the same time are not allowed to join.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back, may be excluded.
  • Patients with known allergies to the study medications are not eligible.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded.
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Investigated drugs

  • mFOLFIRINOX

    is a combination chemotherapy treatment used in this trial. It includes several drugs that work together to stop the growth of cancer cells. This combination is often used to treat certain types of cancer after surgery to help prevent the cancer from coming back.

  • Capecitabine

    is a chemotherapy medication that is taken orally. It is used to treat various types of cancer by interfering with the growth of cancer cells. In this trial, it is used as a single-agent treatment option.

  • Gemcitabine

    is another chemotherapy drug used in this trial. It is administered through an injection and works by slowing or stopping the growth of cancer cells. It is used as a single-agent treatment option for patients who have had surgery for ampullary adenocarcinoma.

What is already known about the treatment

  • Capecitabine

    Capecitabine is an oral medication used in the treatment of certain types of cancer, including ampullary adenocarcinoma. It is currently well-established in medical practice and literature as a chemotherapy agent. The main therapeutic indication for capecitabine is to treat cancers by interfering with the growth of cancer cells. At the molecular level, it works by being converted into 5-fluorouracil in the body, which then inhibits the synthesis of DNA in cancer cells, preventing their growth and division. Capecitabine is classified as an antimetabolite, a type of chemotherapy drug.

  • Gemcitabine

    Gemcitabine is administered intravenously and is used to treat various types of cancer, including ampullary adenocarcinoma. It is a well-recognized medication in the medical community and literature. The primary therapeutic use of gemcitabine is to slow or stop the growth of cancer cells. Its mechanism of action involves incorporating itself into the DNA of cancer cells, leading to cell death. Gemcitabine is classified as an antimetabolite, which is a category of chemotherapy drugs.

  • mFOLFIRINOX

    mFOLFIRINOX is a combination chemotherapy regimen administered intravenously, used in the treatment of ampullary adenocarcinoma. It is currently being evaluated in clinical trials for its effectiveness in improving disease-free survival after surgical resection. The regimen includes a combination of drugs that work together to inhibit cancer cell growth by interfering with DNA synthesis and repair. mFOLFIRINOX is classified under combination chemotherapy, utilizing multiple agents to enhance therapeutic effects against cancer.

Investigated diseases

Ampullary adenocarcinoma – Ampullary adenocarcinoma is a type of cancer that forms in the ampulla of Vater, where the bile duct and pancreatic duct join and empty into the small intestine. This cancer can cause symptoms such as jaundice, abdominal pain, and weight loss due to its location affecting bile flow. It typically progresses by invading nearby tissues and can spread to lymph nodes and other organs. The growth of the tumor can obstruct the bile duct, leading to further complications. Early stages may not present noticeable symptoms, making it challenging to detect without medical imaging. As the disease advances, it may lead to more severe symptoms and complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511070-68-01Protocol codeAMPIRINOXEstimated enrolment294 patientsSponsorCentre Hospitalier Universitaire De Dijon

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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).