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Study Comparing Neoadjuvant Chemotherapy with Capecitabine and Oxaliplatin to Standard Treatment for Patients with Locally Advanced Rectal Cancer

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 rectal cancer, a type of cancer that affects the last part of the large intestine. The study is comparing two different approaches to treatment. One group of patients will receive the standard treatment, which includes a combination of radiotherapy (using high-energy rays to kill cancer cells) and chemotherapy (using drugs to kill cancer cells), followed by surgery. The other group will receive an experimental approach that involves only neoadjuvant chemotherapy (chemotherapy given before surgery) followed by surgery.

The medications being studied in this trial include Capecitabine, which is available in different forms such as Capecitabine Pharmacare 150 mg and Capecitabine Glenmark 500 mg film-coated tablets, among others. Another medication used is Oxaliplatin, which is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. Additionally, Fluorouracil and Calcium Folinate are also part of the treatment regimen, with Fluorouracil being a solution for injection and Calcium Folinate being used to reduce the side effects of chemotherapy.

The purpose of this study is to compare the long-term and short-term outcomes of these two treatment approaches in patients with rectal cancer. Participants will be randomly assigned to one of the two treatment groups. The study will monitor various outcomes, including how long patients remain free of cancer, overall survival rates, and any side effects experienced. The trial aims to provide valuable information on the effectiveness and safety of these treatments for rectal cancer.

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

    Initial assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary imaging tests to evaluate the condition of the rectal cancer.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two groups: the standard treatment group or the experimental treatment group. The standard treatment involves a combination of radio-chemotherapy and surgery, while the experimental treatment involves neoadjuvant chemotherapy followed by surgery.

  3. Step 3

    Chemotherapy administration

    For those in the experimental group, chemotherapy is administered before surgery. This includes the use of capecitabine tablets taken orally, and oxaliplatin given through intravenous infusion. The specific dosage and frequency are determined by the medical team based on individual patient needs.

  4. Step 4

    Surgery

    After completing the chemotherapy regimen, surgery is performed to remove the tumor. The timing and type of surgery depend on the response to the chemotherapy and the overall health of the patient.

  5. Step 5

    Follow-up and monitoring

    Post-surgery, regular follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence. This includes physical exams, imaging tests, and laboratory tests as needed.

  6. Step 6

    Long-term outcomes evaluation

    The trial aims to evaluate both short-term and long-term outcomes, including disease-free survival, overall survival, and quality of life. Participants are monitored over an extended period to gather data on these outcomes.

Who can join the trial?

12 criteria

  • Must have a type of cancer called adenocarcinoma of the rectum, which is located within 15 cm from the anal verge (the opening of the anus).
  • The cancer must be locally advanced, as shown by imaging tests. This means the cancer has grown but has not spread to distant parts of the body.
  • The tumor must be considered removable by surgery, as decided by a team of medical experts.
  • Must have an ECOG performance status of 0 to 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities. A score of 0 means fully active, and 2 means capable of all self-care but unable to carry out any work activities.
  • Must be at least 18 years old.
  • Must have adequate function of the bone marrow, liver, and kidneys to safely receive chemotherapy. This includes:
    • An absolute neutrophil count (a type of white blood cell) of at least 1.5 x 109/L.
    • Thrombocytes (platelets, which help with blood clotting) of at least 100 x 109/L.
    • Bilirubin (a substance made by the liver) no more than 1.5 times the upper normal value.
    • Alanine aminotransferase (an enzyme found in the liver) no more than 3 times the upper normal value.
    • A renal glomerular filtration rate (a test to check how well the kidneys are working) of at least 30 mL/min.
    • For women who can become pregnant and men with partners who can become pregnant, effective birth control must be used. Acceptable methods include an intrauterine device (IUD), vasectomy of the male partner, or hormonal contraceptives.
    • Must provide written and verbal consent to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have rectum cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Neoadjuvant Chemotherapy

    is a treatment given before the main treatment, which in this trial is surgery. It involves using drugs to shrink the tumor in the rectum before it is surgically removed. This approach aims to make the surgery more effective and potentially improve the patient's recovery and long-term health outcomes.

  • Standard Treatment (Radio-Chemotherapy)

    combines radiation therapy and chemotherapy. Radiation therapy uses high-energy rays to target and kill cancer cells in the rectum, while chemotherapy uses drugs to stop the growth of cancer cells. This combination is used to reduce the size of the tumor and eliminate cancer cells, making it easier to remove the tumor surgically.

What is already known about the treatment

Neoadjuvant Chemotherapy – Neoadjuvant chemotherapy is administered intravenously, meaning it is given through a vein, usually in the arm. This treatment is currently being studied in clinical trials for its effectiveness in treating locally advanced rectal cancer. The main therapeutic indication for neoadjuvant chemotherapy in this context is to shrink tumors before surgery, potentially improving surgical outcomes. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and division. It is classified pharmacologically as an antineoplastic agent, which means it is used to prevent the growth and spread of cancer cells.

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. The progression of rectal cancer can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The disease may continue to advance if not managed, affecting the function of the rectum and surrounding tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517748-76-00Estimated enrolment124 patientsSponsorRegion Sjaelland

sourced from the EU Clinical Trials Register and site verification

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