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

Based on the provided trial data, I cannot create specific medication descriptions as no medications are explicitly listed in the source data. The trial appears to be comparing different treatment approaches (chemotherapy alone versus chemotherapy plus chemoradiotherapy) for rectal cancer, but specific medications are not mentioned in the provided information. To properly create medication descriptions in the requested format, I would need specific information about the medications used in the trial's chemotherapy and chemoradiotherapy protocols. If you could provide the specific medications used in this trial, I would be happy to create descriptions following the format: Medication Name – description in a single paragraph following all the specified requirements.

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 7 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

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