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Study on Chemotherapy with Irinotecan, Fluorouracil, and Oxaliplatin for Patients with Metastatic Colorectal Cancer After Surgery or Ablation

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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 chemotherapy in patients with metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study will use several medications, including irinotecan hydrochloride trihydrate, fluorouracil, oxaliplatin, capecitabine, disodium folinate, and calcium folinate pentahydrate. These medications are commonly used in cancer treatment and will be administered either through infusion, which is a method of delivering medication directly into the bloodstream, or orally in the form of tablets.

The purpose of this study is to compare the effectiveness of additional chemotherapy after the surgical removal or destruction of cancerous growths, known as metastases, with a structured follow-up approach. Participants in the study will receive treatment over a period of up to 24 months. During this time, they will be monitored regularly to assess their health and the progression of the disease. The study aims to determine whether the additional chemotherapy can help improve outcomes for patients by preventing the cancer from returning or spreading further.

Participants will be randomly assigned to different treatment groups, and some may receive a placebo. The study is designed to be open, meaning both the participants and the researchers will know which treatment is being administered. The main goal is to evaluate the time it takes for the disease to progress or for the patient to pass away, which is referred to as progression-free survival. This information will help researchers understand the potential benefits of post-surgery chemotherapy in managing metastatic colorectal cancer.

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, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the trial.

    The patient must have a confirmed diagnosis of metastatic colorectal cancer and have undergone successful surgery or treatment of metastases within 3 to 10 weeks prior to joining the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient meets all eligibility criteria, including adequate organ function and no active metastatic disease as confirmed by recent imaging tests.

    The patient's ability to metabolize fluorouracil effectively is evaluated. If necessary, dosage adjustments are made based on specific test results.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of chemotherapy drugs. The medications used include irinotecan hydrochloride trihydrate, fluorouracil, oxaliplatin, capecitabine, disodium folinate, and calcium folinate pentahydrate.

    Most of these medications are given through an infusion, except for capecitabine, which is taken orally. The specific dosage and frequency depend on the patient's treatment plan.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's response to treatment and to check for any side effects.

    Progression-free survival is assessed at 24 months to determine the effectiveness of the treatment.

  5. Step 5

    End of trial

    The trial is estimated to conclude by December 31, 2030. The patient's participation may end earlier if the treatment is completed or if there are any significant health changes.

Who can join the trial?

11 criteria

  • The patient must provide a signed informed consent, which means they agree to participate in the study after understanding all the details.
  • The patient must have a normal ability to process a drug called fluorouracil. This can be shown by having had previous treatment with 5-FU or capecitabine without unusual side effects, or by having a normal test result for DPD deficiency, which is a condition affecting drug metabolism.
  • Women who can have children must have a negative pregnancy test within 14 days before starting the study. They must agree to avoid pregnancy by not having heterosexual intercourse or by using very effective birth control methods during the study and for a certain period after the last dose of treatment. Men must also take precautions to prevent pregnancy in their partners during and after the study.
  • The patient must be at least 18 years old when they sign the informed consent.
  • The patient must have a confirmed diagnosis of a type of cancer called adenocarcinoma in the colon or rectum.
  • The patient must have had their cancer spread (metastases) removed or effectively treated within 3 to 10 weeks before starting the study. The primary tumor must also have been removed.
  • The patient must not have any significant problems with wound healing at the time of starting the study. Any previous wound healing issues must be resolved.
  • The patient must not have any signs of active cancer spread in recent imaging tests like CT or MRI scans.
  • The patient must have an ECOG performance status of 0-2, which is a scale that measures how well they can perform daily activities.
  • The patient must have adequate function of their bone marrow, liver, and kidneys, as shown by specific blood test results.
  • If the patient is not on blood thinners, they must have certain blood clotting test results within normal limits. Patients on blood thinners for prevention or treatment are allowed in the study.

Who cannot join the trial?

10 criteria

  • Patients who have not completed the main treatment for their cancer.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a different type of cancer in the past, unless it was successfully treated and has not returned.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have certain infections that could affect the study results.
  • Patients who have received certain treatments recently that could interfere with the study.
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Investigated drugs

  • FOLFIRI

    is a combination chemotherapy regimen used to treat colorectal cancer. It includes three medications: irinotecan, fluorouracil, and leucovorin. This combination works by interfering with the growth of cancer cells, slowing their spread in the body.

  • FOLFOX

    is another chemotherapy regimen for colorectal cancer, consisting of oxaliplatin, fluorouracil, and leucovorin. It helps to stop the growth of cancer cells by damaging their DNA and preventing them from dividing.

  • Bevacizumab

    is a targeted therapy that works by inhibiting the growth of blood vessels that supply nutrients to tumors. This can help to slow or stop the growth of cancer.

  • Cetuximab

    is a monoclonal antibody that targets specific proteins on the surface of cancer cells, blocking their ability to grow and divide. It is used in the treatment of colorectal cancer.

  • Panitumumab

    is another monoclonal antibody that targets cancer cells by binding to a specific protein, preventing the cells from growing and spreading. It is used in the treatment of colorectal cancer.

What is already known about the treatment

Bevacizumab – Bevacizumab is administered intravenously and is used in the treatment of metastatic colorectal cancer. It is currently well-established in medical practice and literature as a treatment option for this condition. The main therapeutic indication for bevacizumab is to inhibit the growth of blood vessels that supply tumors, thereby slowing or stopping tumor growth. At the molecular level, it works by blocking a protein called vascular endothelial growth factor (VEGF), which is responsible for the formation of new blood vessels. Bevacizumab is classified as an angiogenesis inhibitor.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. The disease progresses as cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms may include changes in bowel habits, abdominal pain, and unexplained weight loss. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. The focus of treatment is often on managing symptoms and slowing the spread of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512174-10-00Protocol codeFIRE-9 - PORTEstimated enrolment507 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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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).