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Study Comparing Surgery and Chemoradiotherapy with Capecitabine for Early Rectal Cancer Patients

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 treatments for early rectal cancer. The study compares two different approaches: radical surgery and a combination of treatments called adjuvant chemoradiotherapy, which is given after a local excision of the cancer. The local excision is a procedure where the cancer is removed from the rectum without taking out the entire rectum. The aim is to see if preserving the rectum with these treatments is safe and effective for patients with intermediate-risk early rectal cancer.

One of the treatments being studied involves the use of a medication called capecitabine, which is available in the form of Xeloda 150 mg film-coated tablets. This medication is taken orally, meaning it is swallowed in the form of a pill. The study will also involve monitoring patients through regular check-ups and imaging tests like MRI to ensure the cancer has not returned and to assess the overall health and quality of life of the participants.

The study will follow participants over several years to gather information on the recurrence of cancer, any side effects from the treatments, and the overall survival of the patients. The goal is to determine if the rectal-preserving approach is a viable option for treating early rectal cancer, potentially offering patients a treatment that maintains more of their normal bodily functions and quality of life.

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, eligibility is confirmed based on specific criteria, including a previous local excision of early rectal cancer and the absence of carcinoma in the resection plane.

    Participants must be over 18 years old, medically fit, and have a life expectancy of at least 12 months.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to one of two groups: radical surgery or adjuvant chemoradiotherapy after local excision.

    The choice of treatment is based on the study's aim to compare the safety and effectiveness of these approaches.

  3. Step 3

    Medication administration

    For those receiving adjuvant chemoradiotherapy, the medication capecitabine is administered orally.

    The specific product used is Xeloda 150 mg film-coated tablets.

  4. Step 4

    Treatment duration

    The duration of the treatment varies depending on the assigned group and individual response to therapy.

    Participants are monitored closely throughout the treatment period to assess effectiveness and manage any side effects.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status and treatment outcomes.

    Functional outcomes and quality of life are assessed using validated questionnaires at various intervals: admission, 3, 6, 12, 24, and 36 months post-operatively.

  6. Step 6

    End of study

    The study is estimated to conclude by January 1, 2030.

    Primary and secondary endpoints, such as local recurrence rate and long-term morbidity, are evaluated to determine the success of the treatment.

Who can join the trial?

15 criteria

  • The patient has had a local removal of early rectal cancer using specific methods, without cancer in the removed tissue edges.
  • Male or female, older than 18 years.
  • Expected to live for at least 12 more months.
  • Medically fit to undergo major surgery or radiation, with a health status of WHO 0-2 (a scale that measures general health).
  • No issues that prevent chemotherapy, including having enough healthy blood cells and normal liver and kidney function.
  • The patient is willing and able to follow the study plan and attend all follow-up visits and tests.
  • Has given written consent to participate and can follow the study plan.
  • Patients with uncertain tissue removal edges are eligible if no visible tumor is found during a follow-up procedure.
  • Patients with cancer in the tissue edges are eligible after a second removal shows no cancer in the edges.
  • Only patients needing a specific type of surgery (TME) can join; those needing a different surgery (PME) cannot.
  • Pathology confirms rectal cancer with specific features: T1 stage, size 3-5 cm, or pT1 stage, size up to 3 cm, with certain aggressive features.
  • Pathology confirms rectal cancer with specific features: pT2 stage, size up to 3 cm, well or moderately differentiated, without spread to lymph or blood vessels.
  • A complete colonoscopy shows no other colorectal cancer.
  • No cancer spread to lymph nodes, confirmed by a pelvic MRI, with lymph nodes smaller than 10 mm considered non-cancerous.
  • Proper imaging tests (X-ray or CT scans) show no signs of cancer spread to other parts of the body.

Who cannot join the trial?

3 criteria

  • Patients who do not have rectal cancer cannot participate. Rectal cancer is a type of cancer that affects the last part of the large intestine.
  • Patients who are not in the specified age range cannot participate. The study is open to certain age groups, but the exact ages are not specified here.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection, like children or those with certain disabilities.
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Investigated drugs

  • Adjuvant Chemoradiotherapy

    is a treatment that combines chemotherapy and radiation therapy. It is used after the initial surgical removal of cancer to help eliminate any remaining cancer cells and reduce the risk of cancer returning. This therapy aims to enhance the effectiveness of the surgery and improve the overall outcome for patients with early rectal cancer.

  • Completion Surgery

    refers to an additional surgical procedure that may be performed after the initial local excision of rectal cancer. This surgery aims to ensure that all cancerous tissue has been removed and to prevent the cancer from coming back. It is considered when there is a concern that the initial surgery might not have completely removed the cancer.

What is already known about the treatment

Adjuvant Chemoradiotherapy – This treatment is administered through a combination of chemotherapy and radiation therapy, typically applied after surgical procedures. It is currently being studied in clinical trials for its effectiveness in treating early rectal cancer, particularly in preserving the rectum and avoiding more radical surgery. The main therapeutic indication is for patients with intermediate-risk early rectal cancer. The mechanism of action involves using chemotherapy to sensitize cancer cells to radiation, thereby enhancing the effectiveness of radiation therapy in destroying cancer cells. This treatment falls under the pharmacological classification of adjuvant cancer therapies, which are used to support primary treatments like surgery.

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 typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, such as diarrhea or constipation, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517410-15-01Estimated enrolment315 patientsSponsorAmsterdam UMC

sourced from the EU Clinical Trials Register and site verification

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