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Study on the Effectiveness of Neoadjuvant Chemotherapy with Oxaliplatin and Capecitabine for Patients with Locally Advanced Colon 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 the effectiveness of a treatment for locally advanced colon cancer. The treatment being tested involves a combination of medications and procedures. The medications used in this study are Oxaliplatin, which is given as a solution through a vein, and Capecitabine, which is taken as a tablet by mouth. These medications are part of a treatment plan called neoadjuvant chemotherapy, which is given before surgery to help shrink the tumor.

The purpose of the study is to determine if this treatment approach, which includes chemotherapy before surgery, followed by surgery and additional chemotherapy, can improve the time patients remain free from cancer after surgery, compared to the standard treatment of surgery followed by chemotherapy. The study will follow participants over a period of time to see if this new approach helps them stay cancer-free for longer.

Participants in the study will receive the treatment over a period of several months. The study will monitor their health and progress, looking at how well the treatment works and any side effects that may occur. The goal is to see if this new treatment plan can help improve outcomes for people with locally advanced colon 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

    Initiation of treatment

    The treatment begins with the administration of neoadjuvant chemotherapy. This involves receiving medications before surgery to help shrink the tumor.

    The medications used are oxaliplatin and capecitabine. Oxaliplatin is given as a solution for infusion, which means it is administered through a vein. Capecitabine is taken orally in the form of film-coated tablets.

  2. Step 2

    Chemotherapy administration

    Oxaliplatin is administered intravenously. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

    Capecitabine tablets are taken by mouth. The dosage and frequency will also be determined by the healthcare provider.

  3. Step 3

    Surgical procedure

    After completing the neoadjuvant chemotherapy, a surgical procedure is performed with the intent to remove the tumor completely.

    The surgery is planned to be curative, aiming for no remaining cancerous tissue.

  4. Step 4

    Post-surgery chemotherapy

    Following surgery, additional chemotherapy may be administered to eliminate any remaining cancer cells and reduce the risk of recurrence.

    The same medications, oxaliplatin and capecitabine, may be used in this phase, with dosages and schedules tailored to individual recovery and health status.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence.

    These appointments may include physical exams, imaging tests, and blood tests to ensure the effectiveness of the treatment and to address any side effects.

Who can join the trial?

15 criteria

  • The patient must have a confirmed diagnosis of a type of colon cancer called colon adenocarcinoma.
  • The disease must be able to be removed by surgery, as shown by imaging tests.
  • The patient should be planning to have surgery aimed at completely removing the cancer.
  • Both men and women who are over 18 years old can participate.
  • The patient should be in good overall health, which means they can perform daily activities with little or no help.
  • Blood tests at the time of joining the study should show:
    • Hemoglobin levels greater than 10 grams per deciliter (g/dL). Hemoglobin is a protein in red blood cells that carries oxygen.
    • Leukocytes (white blood cells) greater than 3.0 billion per liter (109/L). These cells help fight infections.
    • Platelets greater than 100,000. Platelets help with blood clotting.
    • Glomerular Filtration Rate greater than 50 milliliters per minute (ml/min). This measures how well the kidneys are working.
    • Total Bilirubin less than 25 micromoles per liter (micromol/L). Bilirubin is a substance made during the normal breakdown of red blood cells.
    • The patient should not have any medical reasons that would prevent them from receiving chemotherapy.
    • The patient must agree to participate and sign a document called the Informed Consent, which explains the study and its risks.
    • Imaging tests, like a CT scan, should show signs of a tumor that has grown into the wall of the colon by more than 5 millimeters (mm).
    • The patient may or may not have cancer in the lymph nodes, as shown by a CT scan.
    • The patient should not have cancer that has spread to other organs.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than locally advanced colon cancer (LACC) cannot participate. This means the cancer is in the colon and has spread to nearby areas but not to distant parts of the body.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Neoadjuvant Chemotherapy

    is a treatment given before the main treatment, which in this case is surgery. It is used to shrink the tumor in locally advanced colon cancer, making it easier to remove during surgery. This approach aims to improve the chances of successful surgery and reduce the risk of cancer returning.

  • Surgery

    is the main treatment for colon cancer, where the surgeon removes the part of the colon containing the cancer. The goal is to remove all cancerous tissue and any nearby lymph nodes that might be affected.

  • Complementary Chemotherapy

    is given after surgery to kill any remaining cancer cells. This helps to lower the risk of the cancer coming back and aims to improve long-term survival.

What is already known about the treatment

Neoadjuvant Chemotherapy – This treatment is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating locally advanced colon cancer. The main therapeutic indication is to shrink tumors before surgery, making them easier to remove and potentially improving surgical outcomes. At the molecular level, chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and replication. It is classified as an antineoplastic agent, which is a type of medication used to treat cancer.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is part of the digestive system. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may spread to distant organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519825-39-00Protocol codeELECLAEstimated enrolment238 patientsSponsorClinica Universidad De Navarra

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