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Study on Contact X-ray Brachytherapy with Capecitabine for Rectal Cancer Preservation in Adults with Intermediate Stage Rectal Adenocarcinoma

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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 type of cancer called rectal adenocarcinoma, which affects the rectum, a part of the large intestine. The study is specifically looking at cases where the cancer is at an intermediate stage, meaning it is not too small or too large. The main goal of the trial is to see if a treatment called contact X-ray brachytherapy can help preserve the rectum while increasing survival rates. This treatment is being tested in combination with a series of therapies known as total neoadjuvant therapy (TNT), which is a comprehensive approach to treating cancer before surgery.

The trial involves several medications that are commonly used in cancer treatment. These include Capecitabine, which is taken orally as a tablet, and Oxaliplatin, Irinotecan Hydrochloride Trihydrate, Folinic Acid, and Fluorouracil, which are administered through infusions or injections. The study will compare the effects of these medications, along with the contact X-ray brachytherapy, to see if they can effectively treat the cancer while allowing patients to keep their rectum intact.

Participants in the study will receive these treatments over a period of time, and their health will be monitored to assess the effectiveness of the therapy. The study aims to find out if this combination of treatments can help patients live longer without needing major surgery to remove the rectum. The trial will also look at other factors like the quality of life and any side effects that may occur during the treatment process.

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 will begin the process of total neoadjuvant therapy (TNT) for rectal adenocarcinoma. This involves a series of treatments aimed at preserving the rectum.

  2. Step 2

    MFolfirinox chemotherapy

    The patient will start with mFolfirinox chemotherapy, which includes a combination of medications: capecitabine, oxaliplatin, irinotecan hydrochloride trihydrate, folinic acid, and fluorouracil.

    Capecitabine is taken orally in the form of 150 mg film-coated tablets.

    Oxaliplatin, irinotecan hydrochloride trihydrate, folinic acid, and fluorouracil are administered intravenously as solutions for infusion or injection.

    The chemotherapy is administered in cycles, with the patient receiving up to four cycles.

  3. Step 3

    Contact X-ray brachytherapy

    Following chemotherapy, the patient will undergo contact X-ray brachytherapy. This is a targeted radiation treatment aimed at preserving the rectum and increasing survival rates.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored.

    Regular assessments will be conducted to evaluate anorectal function, quality of life, and any potential surgical complications.

    The patient's overall survival, disease-free survival, and metastasis-free survival rates will be tracked.

  5. Step 5

    Completion of the trial

    The trial is expected to continue until May 2030, with ongoing assessments and follow-ups to ensure the effectiveness and safety of the treatment.

Who can join the trial?

19 criteria

  • Patient with a confirmed diagnosis of rectal adenocarcinoma, a type of cancer in the rectum.
  • Blood and body function tests must be within certain limits:
    • Total Bilirubin should be no more than 1.5 times the normal upper limit.
    • ASAT and ALAT (liver enzymes) should be no more than 5 times the normal level.
    • Creatinine should be no more than 1.5 times the normal level, and creatinine clearance should be more than 60 ml/min.
    • Neutrophils (a type of white blood cell) should be at least 1.5 billion per liter.
    • Platelets (cells that help blood clot) should be at least 150 billion per liter.
    • Hemoglobin (a protein in red blood cells) should be at least 9 grams per deciliter, even if the patient has received a blood transfusion.
    • Albuminemia (a protein in the blood) should be at least 30 grams per liter before starting chemotherapy.
    • Women who can have children must have a negative pregnancy test before starting the study treatment.
    • Sexually active women who can have children must agree to use a highly effective birth control method or not engage in sexual activity during the study and for at least 6 months after the last treatment. This period extends to at least 9 months after the last oxaliplatin infusion, a type of chemotherapy.
    • Patient must be starting mFolfirinox chemotherapy, which is a specific type of cancer treatment. Registration for the study can occur before, during, or after 4 cycles of this chemotherapy.
    • Sexually active male patients must agree to use condoms during the study and for at least 6 months after the last treatment. It is also recommended that their female partners use a highly effective birth control method for the same duration.
    • Patient must understand and sign a consent form before any study-specific procedures are done. They should also be willing to attend study visits and follow procedures.
    • Patient must be part of a social security system or have similar benefits.
    • Patient must have intermediate risk factors, such as a tumor size between 3.1 cm and 6 cm, and specific cancer stages (cT2N1 or T3N0-1, M0).
    • The tumor must be reachable by a digital rectal exam and located in the lower or middle part of the rectum, not significantly affecting the anal canal.
    • Patient must be able to undergo surgery if needed.
    • Patient must be at least 18 years old.
    • Patient must have a WHO status of 0 or 1, which indicates their level of daily activity and health at diagnosis.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients whose cancer has spread to other parts of the body, known as **metastasis**.
  • Patients who have had previous treatments that might interfere with the study.
  • Patients with other serious health conditions that could affect their participation.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not within the specified age range for the study.
  • Patients who do not agree to follow the study's requirements and guidelines.
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Investigated drugs

  • Contact X-ray Brachytherapy (CXB)

    is a type of radiation therapy used in this trial. It involves placing a small source of radiation close to the tumor in the rectum. This method aims to deliver a high dose of radiation directly to the cancer cells while minimizing exposure to surrounding healthy tissues. The goal is to help preserve the rectum and improve survival rates in patients with intermediate-stage rectal cancer.

  • Total Neoadjuvant Therapy (TNT)

    is a comprehensive treatment approach that combines chemotherapy and radiation therapy before surgery. In this trial, TNT is used alongside contact X-ray brachytherapy to enhance the effectiveness of the treatment. The aim is to shrink the tumor and improve the chances of preserving the rectum, ultimately increasing the patient's survival rate.

What is already known about the treatment

Contact X-ray Brachytherapy (CXB) – This treatment is administered directly to the tumor site using a specialized device that delivers high doses of radiation in a very localized manner. It is currently being evaluated in clinical trials for its effectiveness in treating intermediate low or mid rectal adenocarcinoma, particularly in patients who may be eligible for rectal preservation. The main therapeutic indication is to enhance survival rates while preserving the organ in patients undergoing total neoadjuvant therapy. At the molecular level, CXB works by damaging the DNA of cancer cells, leading to cell death and preventing tumor growth. It is classified under radiation therapy, specifically as a form of brachytherapy.

Investigated diseases

Rectal Adenocarcinoma – Rectal adenocarcinoma is a type of cancer that begins in the cells lining the rectum, which is the last part of the large intestine. It typically develops slowly over several years, often starting as a small growth called a polyp. As the disease progresses, the cancer can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes or other parts of the body. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may advance to more severe stages. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506885-30-00Protocol code2023/3684Estimated enrolment212 patientsSponsorInstitut Gustave Roussy

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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.

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