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Study on Vinorelbine for Patients with Metastatic Colorectal 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 a type of cancer known as metastatic colorectal cancer. This is a condition where cancer that started in the colon or rectum has spread to other parts of the body. The treatment being tested in this study is a medication called Vinorelbine, which is taken in the form of soft capsules. Vinorelbine is a type of chemotherapy drug that works by interfering with the growth of cancer cells.

The purpose of the study is to explore how effective Vinorelbine is in treating patients with metastatic colorectal cancer. Participants in the study will receive Vinorelbine and will be monitored over a period of time to see how their cancer responds to the treatment. The study will involve regular check-ups and imaging tests, such as computed tomography (CT) scans, to assess the progress of the disease.

The study aims to determine the percentage of patients who experience a reduction in their cancer size or a complete disappearance of the cancer. Additionally, the study will look at how long patients live without the cancer getting worse, overall survival rates, and any side effects experienced during the treatment. The quality of life of participants will also be evaluated to understand the impact of the treatment on their daily lives.

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 trial

    Upon joining the clinical trial, you will be required to sign an informed consent form. This form confirms that you understand the trial's purpose, procedures, and potential risks and benefits.

    You will need to provide a negative pregnancy test if you are a female of childbearing age, conducted no more than 7 days before starting the study treatment.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your medical history, current health status, and ensuring you meet all the inclusion criteria.

    Your ability to understand the Italian language and adhere to the study requirements will also be assessed.

  3. Step 3

    Treatment phase

    You will begin treatment with vinorelbine, administered in the form of 30 mg soft capsules. The medication can be taken orally or buccally, as directed by the study team.

    The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Regular monitoring

    Throughout the trial, you will undergo regular monitoring to assess your response to the treatment. This includes chest and abdominal computed tomography (CT) scans every 8 weeks.

    Your overall health, including bone marrow, liver, and kidney function, will be regularly evaluated to ensure your safety during the trial.

  5. Step 5

    Response evaluation

    The primary goal is to determine the objective response rate (ORR), which measures the percentage of patients achieving a complete or partial response to the treatment.

    Your response will be evaluated based on the criteria set by the study, and any changes in your condition will be documented.

  6. Step 6

    End of trial

    The trial is expected to conclude by January 15, 2026. At the end of the trial, a final assessment will be conducted to evaluate your overall response to the treatment.

    You will be informed of the trial results and any further steps or follow-up care that may be necessary.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of metastatic colorectal cancer (cancer that has spread from the colon or rectum to other parts of the body).
  • Must have measurable metastatic disease according to RECIST 1.1 criteria (a standard way to measure how well a cancer treatment works).
  • Must provide tissue samples from the cancer for testing.
  • Must not have any evidence of cancer in the brain or the protective layers of the brain and spinal cord, unless previously treated and stable.
  • Must be 18 years of age or older.
  • Must have an ECOG performance status of 0-2, which means the patient is fully active or has some restrictions but can still care for themselves.
  • Must have a life expectancy of more than 3 months.
  • Must have received all standard treatments for metastatic cancer and have experienced a return or worsening of the disease.
  • If female and capable of becoming pregnant, must have a negative pregnancy test within 7 days before starting the study treatment.
  • If capable of becoming pregnant or male, must agree to use effective birth control methods during the study.
  • Must have adequate function of the bone marrow, liver, and kidneys, confirmed by tests within 14 days before starting the study treatment.
  • Must be able to understand the Italian language and agree to participate by signing a consent form.
  • Must be in good enough health to undergo treatment and follow-up visits.
  • Must be able to provide complete documentation of treatment, side effects, and response to the study team.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides metastatic colorectal cancer cannot participate. Metastatic means that the cancer has spread to other parts of the body.
  • Patients who have not been diagnosed with colorectal cancer are not eligible.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
  • Both male and female patients are eligible, but those who do not identify as either may not be eligible.
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Investigated drugs

Vinorelbine is a medication used in this clinical trial to treat patients with metastatic colorectal cancer. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. Vinorelbine is a type of chemotherapy drug that targets rapidly dividing cells, which are a characteristic of cancer. By inhibiting these cells, it aims to reduce the size of tumors and improve the patient's condition.

What is already known about the treatment

Vinorelbine – Vinorelbine is administered as an injection, typically given into a vein by a healthcare professional. It is currently being studied for its effectiveness in treating metastatic colorectal cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The main therapeutic use of Vinorelbine in this context is to inhibit the cancer-promoting functions of a protein called MKK3, potentially slowing down or stopping the growth of cancer cells. At the molecular level, Vinorelbine works by interfering with the formation of microtubules, which are structures that help cells divide and multiply. It is classified as a chemotherapy drug, specifically a vinca alkaloid, which is a type of medication that targets rapidly dividing cancer cells.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. This disease typically begins as a growth, called a polyp, on the inner lining of the colon or rectum. Over time, some polyps can develop into cancer, which can invade deeper layers of the colon or rectum wall. As the cancer progresses, it can spread through the blood or lymphatic system to distant organs, most commonly the liver and lungs. The progression of metastatic colorectal cancer involves the growth of cancerous cells in these new locations, which can affect the function of the involved organs. The disease can lead to various symptoms depending on the organs affected, such as abdominal pain, changes in bowel habits, or weight loss.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519459-27-00Protocol codeVIMACEstimated enrolment25 patientsSponsorI.F.O. Istituti Fisioterapici Ospitalieri

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