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A Study of Watchful Waiting After Chemotherapy and Radiotherapy Compared to Surgery for Patients with Early Rectal Cancer Using Capecitabine

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 is looking at rectal cancer, which is a type of cancer that develops in the rectum, the last part of the large intestine before the anus. The study will use capecitabine, a medicine given as tablets by mouth that is used to treat cancer. The treatment being studied involves either radiation therapy, which uses high-energy rays to kill cancer cells, or a combination of chemotherapy, which uses medicines to destroy cancer cells, together with radiation therapy. Some patients may also receive surgery called total mesorectal excision, which is an operation to remove the rectum and surrounding tissue. The purpose of this study is to see how many patients can achieve a sustained complete disappearance of their cancer one year after treatment.

During the study, patients will receive treatment and then be carefully monitored to see if their cancer has completely disappeared. The monitoring will be done using different methods including magnetic resonance imaging, which is a type of scan that creates detailed pictures of the inside of the body, along with clinical examinations where a doctor checks the patient, and endoscopic examinations where a flexible tube with a camera is used to look inside the rectum. The study aims to find out whether it is possible to save the rectum by watching and waiting after the initial treatment instead of immediately performing surgery.

The study will also look at other important outcomes such as whether the cancer comes back in the same area, whether the cancer spreads to other parts of the body, how long patients survive, whether the rectum can be preserved without surgery, and what side effects or complications occur from the treatment. Additionally, the study will examine how the treatment affects daily life including urinary function, sexual function, bowel function, and whether patients need a stoma, which is an opening created surgically for waste to leave the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    Your treatment will begin with either radiation therapy alone or a combination of radiation therapy with chemotherapy. The specific treatment approach will be determined based on your individual case.

    If chemotherapy is included, you will receive capecitabine, which is an oral medication taken by mouth in the form of film-coated tablets.

    The medication is available as Capecitabine Orion 500 mg tablets.

  2. Step 2

    Post-treatment observation

    After completing the initial treatment, your medical team will monitor your response to therapy.

    The goal is to determine whether the tumor has responded completely to the treatment without requiring surgery.

  3. Step 3

    Evaluation at 1 year

    At 1 year after treatment, you will undergo a comprehensive evaluation to assess your response.

    This evaluation will include an MRI scan, which is an imaging test that uses magnetic fields to create detailed pictures of the inside of your body.

    You will also have a clinical examination, where a doctor will physically examine you.

    An endoscopic examination will be performed, which involves using a thin, flexible tube with a camera to look inside your rectum.

    These tests will determine if you have achieved a clinical complete response, meaning that no signs of cancer can be detected.

  4. Step 4

    Ongoing follow-up

    Throughout the study period, your medical team will monitor various aspects of your health.

    This includes checking for any return of cancer in the original location, appearance of cancer in other parts of the body, and overall survival.

    Your urinary function, sexual function, and bowel function will be assessed.

    Any complications or side effects from treatment will be recorded and managed.

    The presence or absence of a stoma, which is a surgical opening that allows waste to leave the body, will be documented.

    The overall goal is to preserve your rectum and avoid surgery if possible, while ensuring your cancer is effectively treated.

Who can join the trial?

9 criteria

  • You must provide written consent to take part in the trial
  • You must be 18 years of age or older
  • You must have a confirmed adenocarcinoma, which is a type of cancer that starts in gland cells, located in the rectum, which is the last part of the large intestine, and the tumor must be within 12 centimeters from the anal verge, which is the opening at the end of the digestive tract
  • Your tumor must be at a specific stage called TX/T1-3b, which refers to the size and depth of the tumor in the rectal wall, regardless of how large the tumor is
  • You must have no cancer spread to nearby lymph nodes, which are small bean-shaped organs that are part of your immune system
  • You must have no cancer spread to distant parts of the body, meaning the cancer has not traveled to other organs
  • You must have an ECOG performance status of 0-1, which is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 7 days before starting the study and agree to use effective birth control methods approved by a doctor from the time you enter the trial until 6 months after treatment ends
  • If you are a man who has not had a sterilization procedure and your partner can become pregnant, you must agree to use effective birth control methods approved by a doctor from the time you enter the trial until 6 months after treatment ends

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified in the available study information
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Investigated drugs

Based on the clinical trial information provided, this study does not involve any medications or drug therapies. This trial compares different treatment approaches for early rectal cancer, specifically comparing watchful waiting (careful monitoring without immediate surgery) after radiation therapy or chemotherapy combined with radiation therapy versus surgical removal of the rectum and surrounding tissue. The focus is on treatment strategies rather than specific medications.

What is already known about the treatment

I apologize, but I cannot complete this task as requested. The clinical trial data provided does not contain any information about specific medications or their trade names. The trial information shows only the study title, medical condition (rectal cancer), and trial objective, but no medication names or pharmaceutical products are listed in the data. To create medication descriptions in the format you requested, I would need the clinical trial data to include specific medication names or pharmaceutical products being studied. The field "authorizedApplication.authorizedPartI.products.0" is empty in the provided data. If you can provide clinical trial data that includes actual medication names, I would be happy to create the descriptions following your specified format.

Investigated diseases

Rectal Cancer – Rectal cancer is a disease that occurs when abnormal cells grow uncontrollably in the rectum, which is the last part of the large intestine before the anus. These cells form a mass called a tumor that can grow into the wall of the rectum over time. As the disease progresses, the tumor may spread deeper through the layers of the rectal wall. The cancer can also spread to nearby lymph nodes, which are small structures that help fight infection. In more advanced stages, cancer cells may travel through the blood or lymphatic system to other parts of the body, such as the liver or lungs. The disease develops gradually, often starting from small growths called polyps that can become cancerous over many years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522955-25-00Estimated enrolment80 patientsSponsorVaestra Goetalandsregionen

sourced from the EU Clinical Trials Register and site verification

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