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Study on Preserving the Rectum in Early-Stage Rectal Cancer Patients Using Oxaliplatin and Capecitabine with Radiation Therapy

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 early-stage rectal cancer, which is a type of cancer that affects the lower part of the large intestine. The study aims to explore different treatment options to preserve the rectum, which is the final section of the large intestine. The treatments being investigated include a combination of radiation therapy and additional treatments, such as medications or surgery. The medications used in this study are Oxaliplatin and Capecitabine. Oxaliplatin is a type of chemotherapy drug that is administered through an intravenous infusion, meaning it is given directly into a vein. Capecitabine is another chemotherapy drug that is taken orally, meaning it is swallowed in pill form.

The purpose of the study is to assess how well these treatments can help preserve the rectum in patients with early-stage rectal cancer. Participants in the study will receive either the treatment with Oxaliplatin and Capecitabine or a placebo. The study will follow participants over a period of time to monitor the effectiveness of the treatment and any side effects that may occur. The study will also look at how the treatment affects the quality of life of the participants, including any changes in bowel, bladder, and sexual function.

Throughout the study, participants will undergo regular check-ups and assessments to track their progress. The study will last for several years, with the main goal of determining the success rate of organ preservation at 24 months from the start of treatment. Additionally, the study will evaluate other outcomes, such as the rate of cancer regrowth and overall survival of the participants. This research aims to provide valuable insights into the best treatment approaches for preserving the rectum in patients with early-stage 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as having early-stage rectal cancer and being 18 years or older.

    Written informed consent is required to participate in the study.

  2. Step 2

    Initial treatment phase

    The treatment begins with either short- or long-course radiotherapy, depending on the specific requirements of the study.

    This phase aims to prepare the body for further treatment and assess the initial response of the cancer to radiotherapy.

  3. Step 3

    Medication administration

    Two medications are used: oxaliplatin and capecitabine.

    Oxaliplatin is administered through an intravenous infusion, which means it is given directly into a vein.

    Capecitabine is taken orally, meaning it is consumed by mouth in the form of tablets.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Follow-up includes evaluating the success of organ preservation and checking for any signs of cancer regrowth or metastasis.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the proportion of patients with successful organ preservation at 24 months from the start of treatment.

    Secondary outcomes include the assessment of treatment-related side effects, quality of life, and overall survival rates.

Who can join the trial?

6 criteria

  • The patient must have a type of cancer called adenocarcinoma in the rectum, confirmed by a biopsy. A biopsy is a small sample of tissue taken from the body to check for disease.
  • The cancer should be in an early or early-intermediate stage, as shown by an MRI scan. MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
  • The tumor should be located in the lower or middle part of the rectum, and surgery called TME (Total Mesorectal Excision) is needed. TME is a surgery to remove the rectum and surrounding tissue.
  • The patient should have an ECOG performance status of 0-1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must be 18 years old or older.
  • The patient must be able and willing to sign a document called informed consent, which means they understand the study and agree to participate.
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Investigated drugs

  • Radiotherapy

    is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used as a primary treatment to target early-stage rectal cancer, aiming to reduce the size of the tumor or eliminate it entirely.

  • Transanal Surgery

    is a minimally invasive surgical procedure used to remove cancerous tissue from the rectum. In this trial, it is considered as an option for patients who have responded well to radiotherapy, allowing for the removal of any remaining cancer cells while preserving the rectum.

  • Systemic Treatment

    involves the use of medications that travel through the bloodstream to reach cancer cells throughout the body. This can include chemotherapy or other drug therapies that help to enhance the effects of radiotherapy and surgery, aiming to prevent the spread of cancer and improve overall treatment outcomes.

  • Watchful Waiting

    is a strategy where doctors closely monitor a patient's condition without giving any immediate treatment. In this trial, it is used for patients who show a good response to radiotherapy, allowing doctors to observe if the cancer remains stable or continues to shrink without further intervention.

What is already known about the treatment

Capecitabine – Capecitabine is an oral medication used in the treatment of early-stage rectal cancer. It is currently well-documented in medical literature and is often used in combination with other treatments like radiotherapy. The main therapeutic indication for capecitabine is to treat certain types of cancer, including rectal cancer, by interfering with the growth of cancer cells. At the molecular level, capecitabine is converted into 5-fluorouracil in the body, which inhibits the synthesis of DNA in cancer cells, thereby preventing their growth and division. It is classified as an antimetabolite, a type of chemotherapy drug.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. In early stages, the cancer may be confined to the rectal wall, but as it progresses, it can invade deeper layers and spread to nearby lymph nodes. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant organs. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514620-17-00Estimated enrolment210 patientsSponsorStichting Radboud University Medical Center

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