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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Acopozfx Uskjeynuqc Heikuvox	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	17.02.2025

Trial locations

Investigated drugs:

Fluorouracil

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.

Investigated diseases:

Colorectal cancer metastatic

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.

Trial ID:

2024-519600-27-00

Protocol code:

DSEE-CRC

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?