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Study on the Effectiveness of Chemotherapy with Fluorouracil, Capecitabine, and Oxaliplatin for Patients with Small Bowel 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 the effects of adjuvant chemotherapy in patients with small bowel adenocarcinoma, a type of cancer that occurs in the small intestine. The study will evaluate the benefits of using chemotherapy after surgical removal of the cancer. The medications being tested include Folinic Acid, Capecitabine, Fluorouracil, and Oxaliplatin. These drugs are commonly used in cancer treatment and will be administered in different combinations to see which is most effective.

The purpose of the study is to determine how well these chemotherapy treatments work compared to just observing patients after surgery. Participants will receive either 12 cycles of chemotherapy or 8 cycles if Capecitabine is used. The study will also compare the effectiveness of using Fluorouracil or Capecitabine alone versus in combination with Oxaliplatin. The trial will last for a period of up to 6 months, during which the patients' health and response to the treatment will be closely monitored.

Throughout the study, the main focus will be on disease-free survival, which means the time patients remain free from cancer after treatment. Other aspects such as overall survival, side effects of the chemotherapy, and quality of life will also be assessed. The study aims to provide valuable information on the best treatment approach for patients with small bowel adenocarcinoma following surgery.

The research process

The trial runs in 6 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 registered and randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the study treatments.

  2. Step 2

    Treatment plan

    The study involves evaluating the benefit of adjuvant chemotherapy after surgery for small bowel adenocarcinoma. Adjuvant chemotherapy is additional cancer treatment given after the primary treatment to lower the risk of the cancer returning.

    You may receive one of the following treatments: 12 cycles of chemotherapy with fluorouracil and oxaliplatin, or 8 cycles of chemotherapy with capecitabine. The specific medications and their combinations will depend on the group you are assigned to.

  3. Step 3

    Medication administration

    Folinic acid and fluorouracil will be administered through an intravenous (IV) infusion, which means the medication is given directly into a vein.

    Capecitabine is taken orally, meaning you will swallow the medication in pill form.

    Oxaliplatin is also administered through an IV infusion.

  4. Step 4

    Treatment duration

    The treatment will last for either 12 cycles or 8 cycles, depending on the specific chemotherapy regimen you are assigned to. Each cycle typically lasts a few weeks, and your healthcare team will provide specific details about the schedule.

  5. Step 5

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. During these visits, your overall survival and any side effects from the chemotherapy will be assessed.

    Your quality of life will also be evaluated using specific questionnaires designed to understand how the treatment affects your daily life.

  6. Step 6

    End of study participation

    Your participation in the study will conclude after the completion of the treatment cycles and follow-up assessments. The study aims to determine the disease-free survival, which is the time from randomization to the first occurrence of cancer recurrence, a new primary tumor, or death.

Who can join the trial?

10 criteria

  • The patient must have had a complete surgical removal (called R0 resection) of stage I, II, or III small bowel adenocarcinoma.
  • The patient must provide a dated and signed informed consent before joining the study.
  • No remaining or spread of cancer should be visible on a CT or MRI scan of the chest, abdomen, and pelvis.
  • The patient must be registered and randomly assigned to a treatment group within 12 weeks after surgery and should be able to start chemotherapy within 14 weeks after surgery.
  • The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The patient must be at least 18 years old.
  • Blood tests must show: neutrophils (a type of white blood cell) of at least 2000 per mm3, platelets (cells that help with blood clotting) of at least 100,000 per mm3, hemoglobin (a protein in red blood cells) of at least 9 g/dL (transfusions are allowed), and bilirubin (a substance made during the breakdown of red blood cells) no more than 1.5 times the upper limit of normal.
  • ASAT and ALAT (liver enzymes) must be no more than 2.5 times the upper limit of normal.
  • Creatinine clearance (a measure of kidney function) must be greater than 50 mL/min, calculated using the Cockcroft-Gault formula.
  • Women who can have children must use contraception during treatment and for at least 4 months after stopping treatment. Men must use contraception during treatment and for at least 6 months after stopping treatment. Post-menopausal women must have not had a menstrual period for at least 12 months to be considered not able to have children.

Who cannot join the trial?

7 criteria

  • Patients who have not had surgery to remove stage I-III small bowel adenocarcinoma cannot participate.
  • Patients who are unable to undergo chemotherapy treatment cannot participate.
  • Patients with other types of cancer that have not been treated or are currently being treated cannot participate.
  • Patients with serious health conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
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Investigated drugs

  • 5-FU

    is a type of chemotherapy medication used in this clinical trial. It works by interfering with the growth and spread of cancer cells in the body. In this study, it is used as an adjuvant treatment, which means it is given after surgery to help reduce the risk of cancer coming back. Patients may receive 5-FU alone or in combination with another medication to see which approach is more effective.

  • Capecitabine

    is another chemotherapy medication being tested in the trial. It is taken orally and is designed to stop cancer cells from growing and dividing. Like 5-FU, capecitabine is used as an adjuvant treatment after surgery for small bowel adenocarcinoma. The trial aims to determine if capecitabine alone or in combination with another drug is more beneficial for patients.

  • Oxaliplatin

    is a chemotherapy drug that is used in combination with either 5-FU or capecitabine in this study. It works by damaging the DNA of cancer cells, which prevents them from multiplying. The trial is investigating whether adding oxaliplatin to the treatment regimen improves outcomes for patients who have had surgery for small bowel adenocarcinoma.

What is already known about the treatment

  • 5-FU (Fluorouracil)

    This medication is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is currently used in medicine to treat various types of cancer, including small bowel adenocarcinoma, and is well-documented in medical literature. The main therapeutic indication for 5-FU is as a chemotherapy agent to help prevent cancer cells from growing and spreading. At the molecular level, 5-FU works by interfering with the DNA and RNA of cancer cells, which are essential for their growth and division. It is classified pharmacologically as an antimetabolite, a type of drug that mimics the building blocks of DNA and RNA, disrupting their normal function.

  • Capecitabine

    This medication is taken orally in the form of tablets, making it convenient for patients to use at home. It is widely recognized in the medical community for its role in treating various cancers, including small bowel adenocarcinoma. Capecitabine is primarily used as a chemotherapy drug to stop cancer cells from growing and spreading. It works by being converted into 5-FU in the body, where it then disrupts the DNA and RNA of cancer cells, preventing their growth. Capecitabine is classified as an antimetabolite, similar to 5-FU, targeting the genetic material of cancer cells.

  • Oxaliplatin

    This medication is administered intravenously, typically in a clinical setting, as part of a chemotherapy regimen. It is well-established in medical literature for its effectiveness in treating various cancers, including small bowel adenocarcinoma. Oxaliplatin is used to enhance the effects of other chemotherapy drugs, like 5-FU or capecitabine, in stopping cancer cell growth. At the molecular level, oxaliplatin works by binding to the DNA in cancer cells, causing damage that prevents them from dividing and growing. It is classified as a platinum-based chemotherapy drug, known for its ability to disrupt the DNA of cancer cells.

Investigated diseases

Small Bowel Adenocarcinoma – Small bowel adenocarcinoma is a type of cancer that originates in the glandular cells lining the small intestine. It typically begins in the duodenum, jejunum, or ileum, which are parts of the small intestine. The disease progresses as the cancer cells grow and invade surrounding tissues, potentially spreading to nearby lymph nodes and other organs. As the tumor enlarges, it can cause blockages in the intestine, leading to symptoms such as abdominal pain, nausea, and weight loss. Over time, the cancer may metastasize to distant organs, complicating the disease course. The progression of small bowel adenocarcinoma can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515299-11-00Protocol codePRODIGE 33 -BALLADEstimated enrolment100 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).