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Study on Recurrent Colorectal Liver Metastases: Evaluating Calcium Folinate, Fluorouracil, Capecitabine, Oxaliplatin, and Irinotecan in a Drug Combination for Eligible Patients

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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 treatments for colorectal liver metastases, which are cancerous growths that have spread from the colon or rectum to the liver. The study will explore the effectiveness of different treatments, including repeat local treatments and a type of therapy given before the main treatment, known as neoadjuvant systemic therapy. The medications involved in this study include Leucovorine Sandoz, Fluorouracil Accord, Capecitabine Accord, Oxaliplatine Accord, and Irinotecan Accordpharma. These medications are used in various forms such as capsules, tablets, and solutions for injection or infusion.

The purpose of the study is to compare the overall survival of patients receiving these treatments. Participants will be randomly assigned to different treatment groups. The study will monitor patients from the start of their treatment until the end of the study period, which is expected to last until May 2027. During this time, patients will receive their assigned treatments and undergo regular check-ups to assess their health and the progress of their treatment.

Throughout the study, the safety and side effects of the treatments will be closely monitored. The study will also evaluate other factors such as the time it takes for the disease to progress, the length of hospital stays, and the quality of life of the participants. This information will help determine the most effective treatment approach for managing colorectal liver metastases.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the trial, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving either the standard treatment or the experimental treatment.
Step 2
Treatment initiation
If you are assigned to the group receiving systemic therapy, you will begin treatment with a combination of medications. These include calcium folinate pentahydrate, fluorouracil, capecitabine, oxaliplatin, and irinotecan hydrochloride trihydrate.
The medications are administered in different ways: calcium folinate pentahydrate and fluorouracil are given intravenously, capecitabine is taken orally as a tablet, and oxaliplatin and irinotecan hydrochloride trihydrate are also given intravenously.
Step 3
Treatment schedule
The treatment schedule involves receiving these medications at specific intervals. The exact dosage and frequency will be determined by the medical team based on your individual health needs and the trial protocol.
Step 4
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess how the treatment is affecting your condition.
You will also be asked to complete questionnaires about your quality of life and any side effects you may experience.
Step 5
Local treatment
If you have recurrent colorectal liver metastases that are eligible for local treatment, procedures such as partial hepatectomy or thermal ablation may be performed. These procedures aim to remove or destroy cancerous tissue in the liver.
Step 6
End of treatment
The treatment phase of the trial will continue until the medical team determines it is appropriate to stop, based on your response to the treatment and any side effects you may experience.
Step 7
Final assessment
At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment and its impact on your health.
The results will contribute to the understanding of the treatment's potential benefits and risks for future patients.

Who can join the trial?

20 criteria

Must have a histological documentation of the primary colorectal tumor. This means there should be a tissue sample confirming the type of cancer.
Must have a life expectancy of at least 12 weeks.
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Must have adequate bone marrow, liver, and kidney function as shown by specific blood tests done within 7 days before screening. These tests include:
- Hemoglobin level of at least 5.6 mmol/L. Hemoglobin is a protein in red blood cells that carries oxygen.
- Absolute neutrophil count (ANC) of at least 1,500/mm³. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 100*10⁹/L. Platelets help with blood clotting.
- Total bilirubin level of no more than 1.5 times the upper limit of normal. Bilirubin is a substance made during the breakdown of red blood cells.
- ALT and AST levels no more than 2.5 times the upper limit of normal (or 5 times if the liver is involved in the cancer). ALT and AST are enzymes that show how well the liver is working.
- Albumin level greater than 30 g/L. Albumin is a protein made by the liver.
- Serum creatinine level no more than 1.5 times the upper limit of normal or a MDRD of at least 50 ml/min. Creatinine is a waste product filtered by the kidneys, and MDRD is a measure of kidney function.
- Prothrombin time or INR less than 1.5 times the upper limit of normal, unless using certain blood thinners. Prothrombin time and INR measure how well and how fast your blood clots.
- Activated partial thromboplastin time less than 1.25 times the upper limit of normal. This is another test to measure blood clotting.
- Must provide written informed consent, which means agreeing to participate after understanding the study details.
- Must have had local treatment for initial colorectal liver metastases (CRLM).
- Must have at least one recurrent CRLM that can be treated locally, such as with partial hepatectomy (surgical removal of part of the liver) or thermal ablation (using heat to destroy cancer cells).
- Must have a maximum of 5 CRLM.
- Must be able to have surgery to remove tumors with negative margins (R0), meaning no cancer cells are left at the edges, and still have enough healthy liver tissue left.
- The ability to remove or treat tumors should be confirmed with a full examination of the liver, surrounding areas, and nearby lymph nodes.
- Must be older than 18 years.
- Must have an ECOG performance status of 0-2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 being unable to work but able to care for oneself.
- Must have an ASA grade of 1-3. This is a classification of physical health, with 1 being a healthy person and 3 being someone with severe systemic disease.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not related to the liver or colon.
Patients who have had a different cancer in the past 5 years, except for skin cancer that is not melanoma.
Patients who have serious heart problems, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with severe infections that are not being treated.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication.
Patients who are participating in another clinical trial at the same time.
Patients with a history of drug or alcohol abuse in the past 2 years.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.

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Verified sites

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Amsterdam UMC
Amsterdam, The Netherlands
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Maxima Medisch Centrum
Veldhoven, The Netherlands

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Investigated drugs

Neoadjuvant Systemic Therapy is a treatment given before the main treatment to help shrink a tumor or kill cancer cells. In this trial, it is used to treat patients with recurrent colorectal liver metastases. The goal is to make the local treatment more effective by reducing the size of the cancer or slowing its growth. This therapy involves using drugs that travel through the bloodstream to reach cancer cells throughout the body.

What is already known about the treatment

Neoadjuvant Systemic Therapy – This medication is administered through the bloodstream, typically via an intravenous (IV) infusion, allowing it to reach cancer cells throughout the body. In the context of current medical research, it is being studied for its effectiveness in treating recurrent colorectal liver metastases, particularly in combination with local treatments. The main therapeutic goal is to shrink tumors before surgery, making them easier to remove and potentially improving survival rates. At the molecular level, this therapy works by targeting and disrupting specific pathways that cancer cells use to grow and divide. It is classified as a systemic chemotherapy, which means it affects the entire body rather than a specific area.

Investigated diseases

Colorectal liver metastases – Colorectal liver metastases occur when cancer cells from a primary colorectal tumor spread to the liver. This process is known as metastasis, where cancer cells travel through the bloodstream or lymphatic system to form new tumors in the liver. The progression of this disease involves the growth of these secondary tumors, which can affect liver function. Over time, the liver may become enlarged, and its ability to perform vital functions can be compromised. As the disease advances, symptoms such as jaundice, abdominal pain, and weight loss may develop. The progression rate can vary depending on several factors, including the size and number of metastases.