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Study on Fluorouracil and Drug Combination for Patients with Metastatic Colorectal Cancer to Evaluate Drug Sensitivity

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 metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study will use a medication called Fluorouracil, also known by its code name 5-FU, which is a chemical substance used in cancer treatment. The purpose of the study is to evaluate a new diagnostic test called µCAN that helps doctors decide on the best third-line treatment for patients with this type of cancer.

Participants in the study will undergo a biopsy, which is a procedure to remove a small sample of tissue for testing. The study aims to see how well the µCAN test can provide accurate and reliable information to guide treatment decisions. The test results will help doctors choose the most suitable therapy for patients who have not responded to previous treatments. The study will also monitor the safety of the test and any side effects that may occur during the process.

The trial will take place over several years, with the goal of collecting data on how effective the µCAN test is in providing treatment guidance. Participants will be observed for any adverse events related to the test or study procedures, and their experiences with the test will be recorded through a questionnaire. The study will help improve understanding of how to better treat metastatic colorectal cancer using advanced diagnostic tools.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study and understand what it involves.
You must be at least 18 years old and have a specific type of cancer called metastatic colorectal cancer. This means the cancer has spread to other parts of your body, such as the liver or lymph nodes.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet all the necessary criteria for the study. This includes checking your overall health and ensuring your cancer can be assessed through imaging tests.
Your doctor will confirm that you have recently not responded to previous cancer treatments and are eligible for another line of therapy.
Step 3
Biopsy procedure
A biopsy will be performed, which involves taking a small sample of tissue from your cancer. This is necessary to generate a report that will help guide your treatment.
The goal is to successfully obtain a sample that can be analyzed to provide information on the best treatment options for you.
Step 4
Treatment guidance
Based on the biopsy results, a report will be generated to help your doctor decide on the most suitable treatment for your condition.
This report aims to provide guidance for your next line of therapy, ensuring it is tailored to your specific needs.
Step 5
Monitoring and follow-up
Throughout the study, you will be monitored for any side effects or adverse events related to the procedures or treatments.
Regular follow-ups will be conducted to assess your response to the treatment and ensure your safety.
Step 6
Completion of study
The study is expected to continue until March 31, 2029. Your participation will involve regular assessments and monitoring until the study concludes or your treatment plan changes.
Upon completion, your doctor will discuss the outcomes and any further steps in your treatment plan.

Who can join the trial?

7 criteria

Willing and able to give written informed consent for participation in the study. This means you agree to join the study and understand what it involves.
Must be a male or female who is at least 18 years old.
Have a performance status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG). This is a scale used to assess how your disease affects your daily living abilities. A score of 0 means you are fully active, and a score of 1 means you are restricted in physically strenuous activity but can carry out light work.
Have cancer that has spread to the liver, peritoneum (the lining of the abdominal cavity), or lymph nodes, which can be seen on a scan and can be biopsied (a small sample can be taken for testing).
Have recently not responded to the first treatment for cancer that cannot be removed by surgery, and are about to start a new standard treatment.
Eligible for another line of treatment if the current standard treatment fails.
Have laboratory test results from blood samples taken within 14 days before signing the consent form, showing that your organs are working well enough to participate. Specific values will be provided in the study protocol.

Who cannot join the trial?

3 criteria

Patients who do not have metastatic colorectal cancer cannot participate. This means the cancer has spread from the colon or rectum to other parts of the body.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This includes groups that may need special protection or care.

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Verified sites

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Akershus University Hospital
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Lorenskog, Norway

Trial locations

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Investigated drugs

µCAN is a new diagnostic test being studied to help doctors choose the best treatment for patients with metastatic colorectal cancer. This test is designed to provide high-quality and accurate information about how a patient's cancer might respond to different drugs. The goal is to help doctors make better decisions about which medications to use for patients who have already tried other treatments.

Fluorouracil

What is already known about the treatment

µCAN – µCAN is not a medication but a diagnostic test used to help doctors choose the best treatment for patients with metastatic colorectal cancer, especially when other treatments have not worked. It is currently being studied in clinical trials to see how well it can provide reliable and accurate information for doctors. The test is designed to guide doctors in selecting a third-line therapy, which is a treatment given when the first and second treatments have failed. µCAN works by analyzing cancer cells to determine which drugs might be most effective for a specific patient, helping to personalize cancer treatment.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver, lungs, or distant lymph nodes. It begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade deeper layers of the colon or rectum and spread through the blood or lymphatic system. The spread of cancer cells to other organs is known as metastasis, which can lead to the formation of new tumors in these distant sites. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread, while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss.