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Study on the Effectiveness of Fluorouracil, Levoleucovorin, and Oxaliplatin in Patients with Resected 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 for patients with small bowel adenocarcinoma, a type of cancer that occurs in the small intestine. The study aims to evaluate the effectiveness of different chemotherapy treatments following surgery. The treatments being tested include a regimen of fluoropyrimidine alone and a combination of fluoropyrimidine with Oxaliplatin. These medications are used to help prevent the cancer from returning after it has been surgically removed.

The trial will compare the outcomes of patients who receive chemotherapy with those who are simply observed after surgery. Participants will be randomly assigned to one of these groups. The study will last for 24 weeks, during which patients will receive their assigned treatment. The goal is to determine which approach is more effective in preventing the recurrence of cancer and improving overall survival rates.

Throughout the study, patients will be monitored for any side effects and their overall health will be assessed. The trial will also gather information on the characteristics of the cancer and how it responds to treatment. This research is part of a larger global effort to improve treatment options for small bowel adenocarcinoma and to better understand the disease. The findings from this study could help guide future treatment decisions for patients with this type of cancer.

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, the patient will be informed about the trial's purpose and procedures. Consent is required to participate.

    Eligibility criteria include having undergone surgery for small bowel adenocarcinoma and meeting specific health parameters.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: observation or chemotherapy treatment.

    This process ensures that the study results are unbiased and scientifically valid.

  3. Step 3

    Chemotherapy treatment

    If assigned to the chemotherapy group, the patient will receive treatment for 24 weeks.

    The treatment may involve a fluoropyrimidine monotherapy or a combination of fluoropyrimidine and oxaliplatin.

  4. Step 4

    Medication administration

    Medications include fluorouracil, levoleucovorin, oxaliplatin, and capecitabine.

    Fluorouracil and levoleucovorin are administered via intravenous infusion.

    Oxaliplatin is also given through intravenous infusion.

    Capecitabine is taken orally in the form of film-coated tablets.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored.

    Regular visits and tests will be scheduled to assess the patient's condition and any side effects.

  6. Step 6

    End of trial

    The trial is expected to conclude by December 31, 2030.

    The primary goal is to evaluate disease-free survival, while secondary goals include overall survival and treatment side effects.

Who can join the trial?

13 criteria

  • The patient must have had a complete removal of a tumor in the small intestine, known as **R0 resected stage I, II, III, or IV small bowel adenocarcinoma**.
  • The level of **serum bilirubin**, a substance made by the liver, must be less than or equal to 1.5 times the upper limit of normal.
  • The patient must sign and date a form showing they understand the important details of the trial before joining.
  • The patient must be 18 years old or older.
  • The patient must be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other trial procedures.
  • There should be no signs of remaining or spreading cancer after surgery, as shown by a physical examination and imaging tests like CT or MRI scans of the chest, abdomen, and pelvis.
  • The patient must be registered and randomly assigned to a treatment group within 14 weeks after surgery and start chemotherapy within 16 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.
  • The **absolute neutrophil count**, a type of white blood cell count, must be at least 1.5 x 109/l.
  • The **platelet count**, which helps with blood clotting, must be at least 100 x 109/l.
  • The **hemoglobin** level, which carries oxygen in the blood, must be at least 90 g/l. Previous blood transfusions are allowed.
  • The levels of **AST and ALT**, enzymes that indicate liver function, must be less than or equal to 2.5 times the upper limit of normal. At least one of these tests must be done.
  • The **creatinine clearance**, a measure of kidney function, must be greater than 50 ml/min, calculated by specific equations or measured directly.

Who cannot join the trial?

8 criteria

  • Patients who have not had surgery to remove the small bowel adenocarcinoma cannot participate.
  • Patients who have other types of cancer, not just small bowel adenocarcinoma, are excluded.
  • Patients who have had chemotherapy or radiation therapy for small bowel adenocarcinoma before the study cannot join.
  • Patients with serious health conditions that could interfere with the study are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits are excluded.
  • Patients who have allergies to the study medications cannot participate.
  • Patients who are part of another clinical trial at the same time are not allowed to join.
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Investigated drugs

  • Fluoropyrimidine

    is a type of chemotherapy medication used in this trial as a single treatment option. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. This medication is being tested to see how effective it is when used alone after surgery in patients with small bowel adenocarcinoma.

  • Oxaliplatin

    is another chemotherapy medication included in the trial. It is used in combination with fluoropyrimidine to see if the two drugs together are more effective than fluoropyrimidine alone. Oxaliplatin works by damaging the DNA of cancer cells, which can lead to their death. This combination therapy is being evaluated for its potential benefits in treating small bowel adenocarcinoma after surgery.

What is already known about the treatment

  • Fluoropyrimidine

    This medication is administered orally or intravenously, depending on the specific formulation used in treatment. It is currently being evaluated in clinical trials for its effectiveness in treating small bowel adenocarcinoma, particularly as an adjuvant therapy following surgery. The main therapeutic indication is for use in patients with resected stage I-IV small bowel adenocarcinoma. At the molecular level, fluoropyrimidine works by interfering with DNA synthesis, thereby inhibiting cancer cell growth and division. It is classified as an antimetabolite in pharmacology.

  • Oxaliplatin

    This medication is administered intravenously and is being studied in combination with fluoropyrimidine for its potential benefits in treating small bowel adenocarcinoma. It is used as an adjuvant therapy in patients who have undergone surgery for stage I-IV small bowel adenocarcinoma. Oxaliplatin's mechanism of action involves forming cross-links in DNA, which prevents cancer cells from replicating and ultimately leads to cell death. It is classified as a platinum-based chemotherapy drug.

Investigated diseases

Small Bowel Adenocarcinoma – This is a rare type of cancer that originates in the small intestine, specifically in the glandular cells lining the small bowel. It often begins as a small growth or polyp that can become cancerous over time. As the disease progresses, it may invade deeper layers of the intestine and potentially spread to nearby lymph nodes or other organs. Symptoms can include abdominal pain, weight loss, and changes in bowel habits, but they may not appear until the disease is advanced. The progression of the disease can vary, with some cases remaining localized while others may spread more extensively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518349-85-01Protocol codeBallad BelgiumEstimated enrolment30 patientsSponsorGroupe Belge D'Oncologie Digestive

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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).