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Study on the Effects of Capecitabine and Oxaliplatin in Patients with Locally Advanced Colon Cancer

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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 effects of a treatment for colon cancer, specifically in cases where the cancer is locally advanced. The treatment being tested is called neoadjuvant chemotherapy, which involves using chemotherapy before the main treatment to shrink the tumor. The medications used in this study are capecitabine and oxaliplatin. Capecitabine is taken orally in the form of a coated tablet, while oxaliplatin is administered as a concentrate for infusion, which means it is given through a vein.

The purpose of the study is to investigate how effective this chemotherapy is in improving the time patients remain free from the disease after treatment. Participants in the study will receive either the neoadjuvant chemotherapy or the standard treatment for colon cancer. The study will last for a period of up to 24 months, during which the effects of the treatment will be monitored and compared.

By participating in this study, researchers aim to gather information on whether the neoadjuvant chemotherapy can help improve outcomes for patients with locally advanced colon cancer. The ultimate goal is to determine if this approach can lead to better long-term results for patients by increasing the time they remain free from cancer after treatment.

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, the patient will be informed about the trial's purpose and procedures. Consent is required to participate.

    Eligibility is confirmed based on specific criteria, including age, health status, and medical history.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's health status. This includes a CT scan to confirm the stage of colon cancer.

    Blood tests are performed to check blood cell counts and liver function.

  3. Step 3

    Treatment phase

    The treatment involves neoadjuvant chemotherapy, which is administered before surgery to shrink the tumor.

    The patient receives two medications: capecitabine and oxaliplatin.

    Capecitabine is taken orally. The dosage and frequency are determined by the healthcare provider based on individual patient needs.

    Oxaliplatin is administered through an injection. The frequency and dosage are also tailored to the patient's condition.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment and manage any side effects.

    Follow-up appointments are scheduled to evaluate the effectiveness of the chemotherapy and plan further treatment if necessary.

  5. Step 5

    End of trial

    The trial aims to assess the two-year disease-free survival rate in patients with locally advanced colon cancer.

    The estimated end date for the trial is December 31, 2026.

Who can join the trial?

9 criteria

  • The patient must have **colon cancer** that is **locally advanced**. This means the cancer is in the colon and has grown into nearby tissues but not spread to distant parts of the body.
  • The cancer must be **T3** (tumor has grown into the outer layers of the colon) or **T4** (tumor has grown through the outer layers and into nearby organs) as confirmed by a **CT scan** (a type of detailed imaging test).
  • The patient must be **18 years or older**.
  • The patient must have a **Performance Status (PS) of 0-2**. This is a measure of how well the patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have certain levels of blood cells: **ANC (Absolute Neutrophil Count) of at least 1.5 x 109/l** and **Thrombocytes (platelets) of at least 100 x 109/l**. These are measures of white blood cells and platelets, which are important for fighting infection and blood clotting.
  • The patient must have certain levels of liver function tests: **Bilirubinemia** (a measure of bilirubin in the blood) must be **3 times or less the upper normal level**, and **ALAT** (a liver enzyme) must be **5 times or less the upper normal value**.
  • The patient must agree to participate in **translational research**, which involves studying samples like blood or tissue to understand the disease better.
  • If the patient is a **fertile woman**, she must have a **negative pregnancy test** and use **secure contraceptives** during the study and for **3 months after treatment** to prevent pregnancy.
  • The patient must provide **written and oral informed consent**, meaning they understand the study and agree to participate.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past 5 years, except for skin cancer that is not melanoma.
  • Patients with serious heart problems, such as heart failure or a recent heart attack.
  • Patients with severe liver disease, which means the liver is not working well.
  • Patients with severe kidney disease, which means the kidneys are not working well.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who have a known allergy to the drugs used in the study.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a mental health condition that makes it hard to understand or follow the study instructions.
  • Patients who have had major surgery in the last 4 weeks.
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Investigated drugs

Neoadjuvant Chemotherapy is a treatment given before the main treatment. In this trial, it is used to shrink tumors in patients with locally advanced colon cancer. The goal is to make the cancer easier to remove with surgery and to improve the chances of disease-free survival. This approach is being compared to the standard treatment to see if it offers better outcomes for patients.

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, potentially improving surgical outcomes and survival rates. At the molecular level, chemotherapy works by targeting and killing rapidly dividing cancer cells, disrupting their growth and replication. It is classified pharmacologically 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 the final part of the digestive tract. It typically 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. The progression of colon cancer can vary, with some cases growing slowly and others more rapidly. Early stages may not show symptoms, but as it advances, symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort may occur.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514294-22-01Protocol codeNeoColEstimated enrolment247 patientsSponsorLillebaelt Hospital

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© 2026 Clinical Trials EU – European Clinical Trials Information Network

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).