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Study on the Effectiveness of FOLFIRINOX and FOLFOX for Patients with Advanced Small Bowel Cancer Using Calcium Levofolinate, Irinotecan, and Oxaliplatin

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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 small bowel adenocarcinoma, which affects the small intestine. The study is evaluating two different treatment combinations for this cancer: modified FOLFIRINOX and FOLFOX. These treatments involve a combination of chemotherapy drugs, including irinotecan hydrochloride trihydrate, oxaliplatin, fluorouracil, and calcium levofolinate. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to assess how well these treatments work in patients with locally advanced or metastatic small bowel adenocarcinoma, meaning the cancer has spread or cannot be removed by surgery. The study will look at the percentage of patients who are alive without their cancer getting worse after eight months. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 36 months, during which patients will be monitored regularly to track their progress and any side effects they may experience.

In addition to the main goal of the study, researchers will also look at overall survival rates and how long patients live without their cancer progressing. This information will help determine the effectiveness of the treatments and provide valuable insights into managing small bowel adenocarcinoma. Participants in the study may receive either the treatment or a placebo, which is a substance with no active medication, to compare the results. The findings from this study could lead to improved treatment options for patients with this type of cancer in the future.

The research process

The trial runs in 4 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 is confirmed to have a histologically proven adenocarcinoma of the small intestine, which includes the duodenum, jejunum, or ileum.

    The patient must have a metastatic or locally advanced tumor that cannot be surgically removed with the intent to cure.

    The patient should not have received any first-line chemotherapy before joining the study.

    The patient must have a measurable lesion according to specific criteria and meet certain health status requirements based on age.

  2. Step 2

    Treatment phase

    The treatment involves two different chemotherapy regimens: modified FOLFIRINOX and FOLFOX.

    The medications used include calcium levofolinate, irinotecan hydrochloride trihydrate, oxaliplatin, and fluorouracil.

    All medications are administered through an intravenous route, which means they are given directly into a vein.

    The specific dosage, frequency, and duration of each medication are determined by the study protocol and the patient's response to treatment.

  3. Step 3

    Monitoring and assessment

    The main objective of the trial is to assess the percentage of patients who are alive without disease progression at 8 months.

    Regular monitoring is conducted to evaluate the patient's response to treatment and to check for any side effects.

    The patient's health status and tumor progression are assessed using established criteria.

  4. Step 4

    Completion of the trial

    The trial is estimated to end by October 2029.

    The primary endpoint is to determine if there is progression of the disease at 8 months.

    Secondary endpoints include overall survival and progression-free survival, which are evaluated throughout the trial.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of **adenocarcinoma** of the small intestine. This means a type of cancer that starts in the glandular cells of the small intestine, which includes the duodenum, jejunum, or ileum.
  • The cancer must be **metastatic** or **locally advanced** and cannot be removed by surgery with the aim of curing the patient. "Metastatic" means the cancer has spread to other parts of the body, and "locally advanced" means it has grown into nearby areas.
  • The patient must not have received any **first-line chemotherapy** before. This means they have not been treated with the initial standard chemotherapy for their cancer.
  • The patient must have a **measurable lesion** according to **RECIST 1.1 criteria**. A lesion is an area of abnormal tissue, and RECIST 1.1 is a set of guidelines used to measure how tumors respond to treatment.
  • The patient must have an **ECOG status** of 2 or less if they are under 70 years old, or 0 or 1 if they are over 70 years old. ECOG status is a scale used to assess how a patient's disease is affecting their daily living abilities, with lower numbers indicating better functioning.
  • The patient must have a **life expectancy** of more than 3 months. This means doctors expect the patient to live longer than 3 months.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides small bowel adenocarcinoma cannot participate. Small bowel adenocarcinoma is a type of cancer that starts in the small intestine.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, are excluded. In situ cervical cancer is a very early stage of cervical cancer.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, cannot join the study. Heart failure means the heart is not pumping blood as well as it should.
  • Patients with uncontrolled high blood pressure are not allowed. Uncontrolled high blood pressure means blood pressure that is not managed well with medication or lifestyle changes.
  • Patients with active infections that need treatment with antibiotics are excluded. Active infections are infections that are currently causing symptoms and need medical treatment.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and baby.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible. This is to ensure that the results of this study are not affected by other treatments.
  • Patients with known allergies to the study medication or its ingredients are excluded. Allergies are reactions by the immune system to certain substances.
  • Patients with severe liver or kidney disease cannot join the study. Liver or kidney disease affects how the body processes and removes substances.
  • Patients with a history of drug or alcohol abuse within the last year are not eligible. Drug or alcohol abuse means using these substances in a way that is harmful to health.
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Investigated drugs

  • FOLFIRINOX

    is a combination of chemotherapy drugs used to treat certain types of cancer, including small bowel adenocarcinoma. It typically includes a mix of medications that work together to stop cancer cells from growing and dividing. This combination is often used when the cancer is advanced or has spread to other parts of the body.

  • FOLFOX

    is another chemotherapy regimen that combines different drugs to treat cancer. It is used to target cancer cells in the small bowel and can help slow down or stop the progression of the disease. This therapy is often chosen based on the specific needs of the patient and the characteristics of the cancer.

What is already known about the treatment

  • FOLFIRINOX

    FOLFIRINOX is administered intravenously, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic small bowel adenocarcinoma. The main therapeutic indication is to manage and treat this type of cancer. At the molecular level, FOLFIRINOX works by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and division. It is classified pharmacologically as a combination chemotherapy regimen, which includes drugs like fluorouracil, leucovorin, irinotecan, and oxaliplatin.

  • FOLFOX

    FOLFOX is also administered intravenously and is used in clinical settings. It is being evaluated in clinical trials for its potential to treat locally advanced or metastatic small bowel adenocarcinoma. The primary therapeutic use is to combat this form of cancer. FOLFOX acts at the molecular level by disrupting the DNA synthesis of cancer cells, preventing them from multiplying. It is classified as a chemotherapy regimen, consisting of drugs such as fluorouracil, leucovorin, and oxaliplatin.

Investigated diseases

Small bowel adenocarcinoma – This is a rare type of cancer that occurs in the small intestine, which is part of the digestive system. It begins in the glandular cells lining the small intestine and can cause symptoms like abdominal pain, weight loss, and changes in bowel habits. As the disease progresses, it may lead to obstruction of the intestine or spread to other parts of the body. The progression can vary, with some tumors growing slowly while others may advance more rapidly. Early stages might not show significant symptoms, making it challenging to detect initially. Over time, the disease can impact the digestive process and overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505486-92-00Protocol codePRODIGE 86Estimated enrolment130 patientsSponsorCentre Hospitalier Universitaire De Dijon

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