Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study comparing preoperative drug combination with irinotecan, fluorouracil, calcium folinate and oxaliplatin for patients with locally advanced resectable rectal cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with locally advanced resectable rectal cancer located in the middle or lower part of the rectum. The research aims to compare two different treatment approaches: using chemotherapy alone versus using chemotherapy followed by combined chemotherapy and radiation therapy before surgery.

The treatment involves several medications given through intravenous infusion, including irinotecan hydrochloride, calcium folinate, fluorouracil, and oxaliplatin. These medications are commonly used to treat various types of cancer and work together to stop or slow down the growth of cancer cells.

During the study, patients will receive treatment over multiple cycles. The effectiveness of the treatment will be monitored for three years after the start of treatment to determine how well it prevents the cancer from returning or spreading. The study will help determine if chemotherapy alone can be as effective as the combination of chemotherapy and radiation therapy in treating this type of rectal 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

    Initial treatment phase

    You will receive preoperative chemotherapy through intravenous infusion. The medications used include:

    - Irinotecan hydrochloride

    - Calcium folinate

    - Fluorouracil

    - Oxaliplatin

  2. Step 2

    Treatment continuation

    Based on your assigned treatment group, you may receive either:

    - Continued chemotherapy alone, or

    - Chemotherapy combined with chemoradiotherapy (radiation therapy with chemotherapy)

  3. Step 3

    Surgical procedure

    After completing the preoperative treatment, a surgical procedure will be performed to remove the rectal tumor

  4. Step 4

    Follow-up period

    Your progress will be monitored for 3 years after starting the treatment

    Regular medical examinations will be conducted to assess your health status

    The study will continue until December 2030

  5. Step 5

    Health monitoring requirements

    If you are of reproductive age, you must use effective birth control during treatment and for 6 months after the last treatment

    Your overall health status should remain stable, with a performance status of 0 or 1 on the WHO/ECOG scale

Who can join the trial?

7 criteria

  • Confirmed rectal cancer located in the middle or lower part of the rectum, within 12 cm from the anal opening (confirmed by MRI scan)

  • Cancer staging must be either:

    • T3N0 (tumor has grown through the bowel wall but hasn't spread to lymph nodes) or
    • T1-T3N+ (tumor of varying size that has spread to nearby lymph nodes)
  • The tumor margin must be more than 2mm from surrounding tissues on MRI scan
  • Age 18 or older
  • Performance status of 0 or 1 (meaning you must be either fully active or restricted only in strenuous activities)
  • Must sign an informed consent form
  • If able to have children, you must agree to use effective birth control during treatment and for 6 months after the last treatment

Who cannot join the trial?

14 criteria

  • Previous treatment with chemotherapy or radiation therapy for rectal cancer
  • Presence of distant metastases (cancer that has spread to other parts of the body)
  • Pregnancy or breastfeeding women
  • Severe heart, kidney, or liver disease that could interfere with treatment
  • Active infections requiring treatment
  • Known allergies to study medications
  • Other active cancers within the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Mental conditions that could affect ability to provide informed consent
  • Inability to undergo MRI examination
  • Participation in other clinical trials within 30 days before starting this study
  • History of inflammatory bowel disease
  • Major surgery within 4 weeks before starting the study
  • Immunodeficiency (weakened immune system) or ongoing immunosuppressive therapy
  • Uncontrolled comorbidities (other medical conditions) that could affect study participation
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Chemotherapy

    This is a treatment that uses powerful medications to kill cancer cells throughout the body. In this trial, it's used before surgery to treat locally advanced rectal cancer. The chemotherapy works by targeting and destroying rapidly dividing cells, including cancer cells.

  • Chemoradiotherapy

    This is a combined treatment that uses both chemotherapy and radiation therapy together. The chemotherapy medications are given along with radiation treatment to make cancer cells more sensitive to radiation. This combination therapy is commonly used in treating rectal cancer before surgery.

What is already known about the treatment

  • Irinotecan

    This medication is given by intravenous infusion, meaning it is delivered directly into a vein through a drip. It is an approved cancer drug that has been studied extensively in medical literature and is used worldwide. Irinotecan is mainly used to treat colorectal cancer, including rectal tumors, and works by blocking an enzyme called topoisomerase I, which stops cancer cells from copying their DNA. It belongs to the class of antineoplastic agents known as topoisomerase I inhibitors.

  • Fluorouracil

    Fluorouracil is administered as an intravenous infusion, a slow drip into a vein. It is a long‑standing, widely accepted chemotherapy drug with a large amount of research supporting its use. The drug is primarily used for colorectal and other gastrointestinal cancers, and it works by mimicking a building block of DNA, causing the cancer cells to make faulty DNA and stop growing. It is classified as an antimetabolite in the antineoplastic drug group.

  • Oxaliplatin

    Oxaliplatin is also given by intravenous infusion, injected into a vein over a short period. It is an approved chemotherapy agent that has been extensively documented in clinical studies. This drug is mainly used for colorectal cancer and works by attaching to DNA and creating cross‑links that prevent cancer cells from dividing. It falls under the class of platinum‑based antineoplastic agents.

  • Calcium Levofolinate

    Calcium levofolinate is administered through an intravenous infusion, delivered directly into the bloodstream. It is a well‑known rescue medication that is routinely used alongside fluorouracil in cancer treatment protocols. The substance helps protect normal cells from the toxic effects of fluorouracil by supplying a form of folate that allows healthy cells to continue making DNA. It is classified as a folinic acid derivative, a type of rescue agent in chemotherapy.

  • Calcium Folinate

    Calcium folinate is given by intravenous infusion, similar to other drugs in this regimen. It is an established medication used to reduce side effects of fluorouracil and other antimetabolite chemotherapies. By providing a ready form of folate, it allows normal cells to repair DNA and reduces the severity of treatment‑related toxicity. It belongs to the folinic acid class of rescue agents for chemotherapy.

Investigated diseases

Rectal Carcinoma - A cancer that develops in the tissues of the rectum, which is the last part of the large intestine. The disease typically begins as small growths called polyps that can become cancerous over time. As the cancer progresses, it can grow through the layers of the rectal wall and potentially spread to nearby tissues. In middle and low locally advanced cases, the tumor has grown into the deeper layers of the rectal wall but remains in a potentially operable area. The condition may involve nearby lymph nodes but has not spread to distant parts of the body.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510580-28-00Estimated enrolment540 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.