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Study on the Effectiveness of Chemotherapy with Folinic Acid, Fluorouracil, and Irinotecan for Patients with Stage III Colon Cancer After Surgery

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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 effectiveness of chemotherapy in patients with colorectal cancer, specifically those with stage III or high-risk stage II colon or upper rectum adenocarcinoma. The study involves patients who have already undergone surgery and standard chemotherapy but still have detectable levels of circulating tumor DNA (ctDNA), which indicates minimal residual disease. The purpose of the study is to assess how well additional treatment can prevent the cancer from coming back.

Participants in the trial will receive one of the following treatments: FOLINIC ACID, FLUOROURACIL, IRINOTECAN, or a combination of TRIFLURIDINE and TIPIRACIL (known as Lonsurf). These medications are commonly used in chemotherapy and will be administered in various forms, such as injections or tablets. Some participants may receive a placebo instead of active treatment. The study will compare the time it takes for the cancer to return in patients receiving these treatments versus those under regular observation.

The trial will last for a period of up to six months, during which patients will be closely monitored. The main goal is to determine the time to recurrence of the disease, while secondary goals include overall survival, disease-free survival, and the time it takes for ctDNA to become undetectable. The study also aims to evaluate the tolerability of the treatments and their impact on the quality of life of the participants. This research is important for understanding how to better manage colorectal cancer in patients who are at risk of recurrence after initial treatment.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma, previously treated with standard chemotherapy.

    A positive ctDNA screening is required, confirmed by a second test on samples collected at the follow-up visit post-chemotherapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.

  3. Step 3

    Treatment phase

    Participants receive treatment based on their assigned group. The treatments include FOLFIRI or Trifluridine Tipiracil, administered according to the study protocol.

    FOLFIRI involves the use of folinic acid, fluorouracil, and irinotecan, administered intravenously. The specific dosage and frequency are determined by the study protocol.

    Trifluridine Tipiracil is taken orally in the form of film-coated tablets. The dosage and frequency are specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes medical examinations and tests to track disease progression and overall health.

    Participants are followed up to evaluate the time to disease recurrence and other outcomes such as overall survival and quality of life.

  5. Step 5

    End of study

    The study is estimated to conclude by September 2029. At this point, final assessments are made to determine the long-term effects and efficacy of the treatments.

Who can join the trial?

9 criteria

  • The patient must have had a type of cancer called **stage III or high-risk stage II colon or upper rectum adenocarcinoma** that was completely removed by surgery and treated with standard chemotherapy.
  • The patient must have a positive result for **ctDNA**, which is a test that looks for cancer DNA in the blood, at a follow-up visit after chemotherapy.
  • The patient must be between **18 and 80 years old**. If the patient is 70 years or older, they must have a score greater than 14 on a questionnaire that checks their overall health.
  • The patient must have a **WHO performance status** of less than 2, which means they are able to carry out daily activities without much help.
  • The patient must not have any signs of disease on a **TAP CT-scan** or **liver MRI**. If the patient cannot have a dye contrast, a **TEP-scan** may be used instead.
  • The patient must have **adequate haematological function**, meaning their blood counts are within a normal range.
  • The patient must have a **tumor sample available** for further testing called **NGS analysis**.
  • The patient must have signed a **written informed consent**, agreeing to participate in the study.
  • The patient must be **affiliated with a social security scheme**.

Who cannot join the trial?

5 criteria

  • Patients who have not completed full treatment, which includes both surgery and chemotherapy, for their colon or upper rectum cancer.
  • Patients who do not have **minimal residual disease**. This means there are no small amounts of cancer cells left in the body after treatment, which can be detected by a test called **ctDNA** (circulating tumor DNA).
  • Patients who are not in **stage III** or **high-risk stage II** of colon or upper rectum cancer. These stages refer to how advanced the cancer is.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Chemotherapy is a treatment that uses drugs to kill cancer cells. In this trial, chemotherapy is used to treat patients who have undergone surgery for stage III colorectal cancer and have positive ctDNA, which indicates minimal residual disease. The goal is to prevent the cancer from coming back by targeting any remaining cancer cells in the body.

What is already known about the treatment

Capecitabine – Capecitabine is an oral medication used in the treatment of colon cancer, particularly in patients with stage III or high-risk stage II colon or upper rectum adenocarcinoma. It is currently being studied in clinical trials to evaluate its effectiveness in patients with positive circulating tumor DNA (ctDNA) after surgery and chemotherapy. Capecitabine works by interfering with the growth of cancer cells, slowing their spread in the body. It belongs to the pharmacological class of antimetabolites, which are drugs that mimic the building blocks of DNA, thereby disrupting cancer cell replication.

Investigated diseases

Colon Carcinoma – Colon carcinoma is a type of cancer that begins in the large intestine, which is part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease progresses as the cancer cells grow and invade nearby tissues, potentially spreading to other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505046-26-00Protocol codePRODIGE 88Estimated enrolment249 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).