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Study on Induction Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, and Oxaliplatin for Patients with High-Risk Locally Advanced Rectal Cancer

Verified siteRegistered drugNo placebo
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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 treatment for locally advanced rectal cancer, a type of cancer that occurs in the rectum and has spread to nearby tissues but not to distant parts of the body. The study is investigating the effectiveness of a combination of chemotherapy drugs known as FOLFOXIRI, which includes irinotecan hydrochloride, calcium folinate (also known as folinic acid), fluorouracil, and oxaliplatin. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if adding this combination of chemotherapy drugs before the standard treatment of chemoradiotherapy can improve the response to treatment in patients with high-risk locally advanced rectal cancer. The study will follow participants over a period of time to see if this approach leads to better outcomes, such as a higher rate of complete response, where no cancer is found after treatment, and to monitor for any side effects or complications from the treatment.

Participants in the study will receive the chemotherapy drugs as an initial treatment, followed by chemoradiotherapy, which combines chemotherapy with radiation therapy. The study will also look at various outcomes, including how long patients remain free from cancer recurrence, the response of the cancer to the treatment as seen on imaging tests like MRI, and the overall survival of the patients. Additionally, the study will collect information on the quality of life of participants and any side effects they experience during the treatment process.

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

    Induction chemotherapy

    The treatment begins with induction chemotherapy using a combination of medications known as FOLFOXIRI. This includes irinotecan hydrochloride trihydrate, folinic acid, fluorouracil, and oxaliplatin.

    Each medication is administered intravenously as a solution for infusion or injection. The specific dosage and frequency will be determined by the healthcare provider based on individual health conditions and response to treatment.

  2. Step 2

    Chemoradiotherapy

    Following the induction chemotherapy, the next phase involves chemoradiotherapy. This combines chemotherapy with radiation therapy to target the cancer cells more effectively.

    The schedule and duration of this treatment will be tailored to the patient's specific needs and will be communicated by the healthcare team.

  3. Step 3

    Surgery evaluation

    After completing chemoradiotherapy, an evaluation will be conducted to determine the response to the treatment.

    Based on the results, a decision will be made regarding the necessity and timing of surgical intervention to remove any remaining cancerous tissue.

  4. Step 4

    Follow-up and monitoring

    Post-treatment, regular follow-up appointments will be scheduled to monitor recovery and check for any signs of recurrence.

    These appointments may include physical examinations, imaging tests, and laboratory tests to ensure ongoing health and address any concerns promptly.

Who can join the trial?

11 criteria

  • Must be **18 years or older**.
  • Must have a **WHO performance score** of 0-1, which means you are in good health and able to carry out daily activities without assistance.
  • Must be fit for a type of chemotherapy called **FOLFOXIRI**, which is a combination of drugs used to treat cancer.
  • Must have a confirmed diagnosis of **rectal cancer** through a test called **histopathology**, which examines tissue under a microscope.
  • The **lower border of the tumor** must be located on or below a specific part of the colon called the **sigmoidal take-off**, as seen on an **MRI** scan of the pelvis.
  • Must have **high-risk locally advanced rectal cancer**, which means the cancer is at a stage where it might not respond well to treatment. This is determined by specific imaging criteria, such as:
    • **Tumor invasion of the mesorectal fascia (MRF+)**, which means the tumor is affecting the tissue surrounding the rectum.
    • **Grade 4 extramural venous invasion (mrEMVI)**, indicating the cancer has spread to veins outside the rectum.
    • **Tumor deposits (TD)**, which are small clusters of cancer cells found near the main tumor.
    • **Bilateral extramesorectal lymph nodes** with a size of 7mm or more, or extensive involvement of these nodes, which are small glands that help fight infection and are located outside the rectum.
    • The disease must be **resectable**, meaning it can be surgically removed, as determined by an **MRI** scan or after initial treatment. If the tumor is expected to remain after surgery or has spread to certain areas, it is not considered resectable.
    • Must provide **written informed consent**, which means you agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than locally advanced rectal cancer cannot participate. This means the cancer is in the rectum and has spread to nearby areas but not to distant parts of the body.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • FOLFOXIRI

    is a combination chemotherapy regimen used in this trial. It includes a mix of different chemotherapy drugs that work together to stop the growth of cancer cells. This combination is used before surgery to shrink tumors in patients with high-risk locally advanced rectal cancer. The goal is to improve the chances of a complete response to treatment.

  • Chemoradiotherapy

    is a treatment that combines chemotherapy with radiation therapy. In this trial, it is used to treat high-risk locally advanced rectal cancer. The chemotherapy helps to make the cancer cells more sensitive to the radiation, which aims to destroy the cancer cells and reduce the size of the tumor before surgery.

What is already known about the treatment

FOLFOXIRI – This medication is administered intravenously and is used in combination with chemoradiotherapy for treating high-risk locally advanced rectal cancer. It is currently being studied in clinical trials to determine its effectiveness in improving response rates compared to standard treatments. The main therapeutic indication is for rectal cancer that is locally advanced and considered high risk. FOLFOXIRI works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as a combination chemotherapy regimen, which includes fluorouracil, leucovorin, oxaliplatin, and irinotecan, each contributing to its overall anti-cancer effects.

Investigated diseases

Locally Advanced Rectal Cancer – This is a type of cancer that occurs in the rectum, which is the last part of the large intestine. It is considered "locally advanced" when the cancer has spread beyond the inner lining of the rectum but has not yet metastasized to distant organs. The disease often involves the surrounding tissues and possibly nearby lymph nodes. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. As the cancer progresses, it can lead to more severe symptoms and complications. The progression of the disease can vary, and it often requires a combination of treatments to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509758-74-00Protocol codeNL74465.100.20Estimated enrolment128 patientsSponsorCatharina Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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