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Study Comparing Short-Course Radiotherapy and Drug Combination for Older Patients with Locally Advanced Rectal Cancer

Fast replyRegistered 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 treatments for locally advanced rectal cancer in older patients. The trial compares two treatment approaches: short-course radiotherapy (SCRT) followed by surgery, with or without additional chemotherapy, and total neoadjuvant therapy (TNT), which involves a combination of treatments given before surgery. The main goal is to determine which approach offers a better balance between effectiveness and safety for older patients.

Participants in the study will receive various medications as part of their treatment. These include Capecitabine, Oxaliplatin, and Fluorouracil, which are commonly used in cancer treatment. Additionally, supportive medications such as Ondansetron, Dexamethasone, Folinic Acid, and Metoclopramide may be administered to help manage side effects and improve the overall treatment experience. Some patients may receive a placebo as part of the study design.

The study will follow participants over a period of time to assess outcomes such as overall survival, progression-free survival, and the occurrence of side effects. The trial aims to provide valuable information on the best treatment strategy for older patients with this type of cancer, ultimately helping to improve their quality of life and treatment outcomes.

The research process

The trial runs in 6 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, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

    You will be required to meet certain criteria, such as being 70 years or older and having a confirmed diagnosis of locally advanced rectal cancer.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status. This includes checking your blood counts, liver and kidney function, and overall physical condition.

    The assessment ensures that you are fit to undergo the treatment planned in the study.

  3. Step 3

    Treatment allocation

    You will be randomly assigned to one of two treatment groups: short-course radiotherapy (SCRT) followed by surgery, with or without additional chemotherapy, or total neoadjuvant therapy (TNT).

    The allocation is random to ensure unbiased results in the study.

  4. Step 4

    Treatment phase

    If you are in the SCRT group, you will receive a short course of radiotherapy. This is followed by surgery, and possibly chemotherapy, depending on your specific case.

    If you are in the TNT group, you will receive a combination of chemotherapy drugs such as ondansetron, oxaliplatin, dexamethasone, folinic acid, metoclopramide, and fluorouracil. These are administered intravenously, meaning they are given through a vein, and the treatment schedule will be explained to you in detail.

  5. Step 5

    Follow-up and monitoring

    Throughout the study, regular follow-up appointments will be scheduled to monitor your health and the effects of the treatment.

    These appointments will include physical exams, blood tests, and possibly imaging tests to assess the progress of your treatment.

  6. Step 6

    End of study participation

    At the end of your participation in the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

    You will be informed about the results and any further steps that may be necessary for your care.

Who can join the trial?

15 criteria

  • Age must be **70 years or older**.
  • Must have signed an **Informed Consent form** before any study-related procedures. This means you agree to participate after being informed about the study.
  • **Male participants** with partners who can become pregnant must agree to use a **condom** during the study and for at least 6 months after the last dose of study drugs.
  • **ECOG performance status**: This is a scale to assess how well you can perform daily activities. If you are over 75 years old, your score should be **0 or 1**. If you are 75 or younger, your score should be **0, 1, or 2**.
  • Must have a confirmed diagnosis of **adenocarcinoma of the rectum** through a tissue sample test.
  • The **tumor** must be located below a certain point in the rectum and within **15 cm of the anal verge** (the opening of the rectum).
  • Must have **operable stage III or high-risk stage II rectal cancer**. High-risk tumors have certain features like being large (T4), close to important structures (mesorectal fascia), or having spread to veins outside the rectum. Involvement of certain lymph nodes is also allowed.
  • Must have **adequate bone marrow function**, which means:
    • **Absolute neutrophil count** (a type of white blood cell) of **1,500/µL or more**.
    • **Hemoglobin** (a protein in red blood cells) of **9 g/dL or more**.
    • **Platelets** (cells that help with blood clotting) of **100,000/µL or more**.
    • Must have **adequate liver function**, which means:
      • **Serum total bilirubin** (a substance made by the liver) of **1.5 times the upper limit of normal (ULN)** or less. If you have **Gilbert’s syndrome**, up to **3 times ULN** is allowed.
      • **AST (SGOT)** and **ALT (SGPT)** (liver enzymes) of **2.5 times ULN** or less.
      • **Alkaline phosphatase** (another liver enzyme) of **2.5 times ULN** or less.
      • Must have **adequate kidney function**, defined by an **estimated glomerular filtration rate (GFR)** of **30 mL/min/1.73m² or more**.
      • Must not have any medical conditions that, in the opinion of the study doctor, would make it unsafe to receive the study treatment or undergo surgery.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides locally advanced rectal cancer cannot participate.
  • Patients who have had previous treatment for rectal cancer are not eligible.
  • Patients with severe heart problems cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients with severe liver or kidney disease cannot participate.
  • Patients with any active infections are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients who are unable to follow the study procedures are excluded.
  • Patients with a history of another cancer within the last 5 years, except for certain skin cancers, are not eligible.
  • Patients who are participating in another clinical trial are excluded.
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Investigated drugs

  • Short-Course Radiotherapy (SCRT)

    is a type of radiation treatment used to shrink tumors in the rectum before surgery. It involves giving a high dose of radiation over a short period, usually within a week. This therapy aims to make the tumor smaller and easier to remove during surgery, potentially improving the chances of a successful operation.

  • Total Neoadjuvant Therapy (TNT)

    is a comprehensive treatment approach that combines chemotherapy and radiation therapy before surgery. The goal of this therapy is to reduce the size of the cancer and eliminate any cancer cells that may have spread, making the surgery more effective. This approach is designed to improve the overall outcomes for patients by addressing the cancer more aggressively before surgical intervention.

What is already known about the treatment

Short-course radiotherapy (SCRT) – This treatment is administered as a form of radiation therapy, typically delivered externally to the body, targeting the tumor in the rectum. It is currently being studied in clinical trials for its effectiveness and safety in treating older patients with locally advanced rectal cancer. The main therapeutic indication is to shrink the tumor before surgery, potentially improving surgical outcomes and reducing the need for more extensive treatments. At the molecular level, SCRT works by damaging the DNA of cancer cells, which prevents them from growing and dividing. It is classified as a type of radiation therapy, a common approach in cancer treatment.

Investigated diseases

Locally Advanced Rectal Cancer – This is a stage of rectal cancer where the tumor has grown into or through the wall of the rectum and may have spread to nearby tissues or lymph nodes, but not to distant body parts. The disease typically begins with abnormal growth of cells in the rectum, which can form a tumor. As the cancer progresses, it can invade surrounding tissues and organs, potentially affecting bowel function. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of the disease can lead to complications such as obstruction of the bowel or spread to nearby organs. Early detection and monitoring are crucial to managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-506703-26-00Protocol codeIJB-SHAPERS-ODN-013Estimated enrolment264 patientsSponsorInstitut Jules Bordet

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