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Study Comparing FOLFIRI with Cetuximab or Bevacizumab for First-Line Treatment in Patients with Metastatic Colorectal Cancer and Specific Genetic Profiles

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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 patients with a type of cancer called metastatic colorectal cancer (mCRC). This cancer has spread from the colon or rectum to other parts of the body. The study is specifically looking at patients whose cancer has certain genetic characteristics, known as RAS/BRAF wild type in tissue and RAS/BRAF mutated in liquid biopsy. The trial will compare two treatment options: one group will receive a combination of chemotherapy drugs called FOLFIRI with cetuximab, and the other group will receive FOLFIRI with bevacizumab.

The purpose of the study is to determine which combination of treatments is more effective in delaying the progression of the cancer. The study will involve regular administration of these medications, which are given through an infusion, meaning they are delivered directly into the bloodstream. The trial will last for a period of up to eight months, during which participants will receive their assigned treatment and be monitored for any changes in their condition.

Participants will be closely observed to assess the safety and effectiveness of the treatments. The study will also look at overall survival rates, how well the cancer responds to the treatment, and the prevalence of the RAS/BRAF mutation in the participants. The trial aims to provide valuable information that could help improve treatment options for patients with metastatic colorectal cancer.

The research process

The trial runs in 5 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, a written informed consent is required.
A blood pregnancy test is necessary for women of childbearing potential within 24 hours before starting the treatment.
Participants and their partners must agree to use contraception during the trial and for a specified period after the last treatment.
Step 2
Initial assessment
An initial assessment will confirm the diagnosis of colorectal adenocarcinoma with RAS/BRAF wild type.
The assessment will ensure the cancer is metastatic and has not been treated with chemotherapy for metastatic disease before.
The patient's overall health, including bone marrow, liver, and kidney function, will be evaluated.
Step 3
Treatment phase
The treatment involves a combination of chemotherapy drugs: FOLFIRI (which includes irinotecan and fluorouracil) plus either cetuximab or bevacizumab.
The medications are administered through intravenous infusion.
The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.
Step 4
Monitoring and follow-up
Regular monitoring will assess the progression of the disease and the patient's response to the treatment.
The primary focus is on progression-free survival, which measures the time during and after treatment that the patient lives with the disease without it getting worse.
Secondary assessments include overall survival, response rate, and safety.
Step 5
End of trial
The trial is expected to conclude by May 4, 2025.
Final evaluations will be conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

12 criteria

Provide written consent to participate in the study.
If the status of a gene called DPD is known, it must be of a normal type. If the status is unknown, there are no restrictions.
Women who can have children must have a negative pregnancy test within 24 hours before starting the study treatment. This includes all women after puberty unless they have not had a period for at least 12 months, have had surgery to prevent pregnancy, or are not sexually active.
Participants and their partners must agree to avoid pregnancy during the study and for 5 months after the last treatment for women who can have children, and 7 months for men with female partners who can have children. They must use effective birth control methods approved by the study doctor.
Participants must be male or female and older than 18 years.
Have a confirmed diagnosis of a type of colon cancer called colorectal adenocarcinoma that is of a specific genetic type known as RAS/BRAF wild type.
Have colon cancer that has spread and cannot be removed by surgery, and have not received chemotherapy for this spread.
Be suitable to receive the first line of chemotherapy treatment.
Have a life expectancy of more than 3 months.
Have at least one area of cancer that can be measured according to specific guidelines called RECIST 1.1.
Have a general health status that is rated as 2 or less on a scale called ECOG Performance Status, which measures daily living abilities.
Have adequate functioning of the bone marrow, liver, and kidneys, as determined before starting the study treatment.

Who cannot join the trial?

5 criteria

Patients who have already received treatment for advanced or metastatic disease cannot participate.
Patients who are not candidates for first-line therapy with FOLFIRI plus cetuximab or bevacizumab are excluded.
Patients with a different diagnosis than mCRC (metastatic colorectal cancer) are not eligible.
Patients who do not have the specific genetic markers being studied (RAS/BRAF mutations) are excluded.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

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Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy

Trial locations

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Investigated drugs

FOLFIRI
is a combination chemotherapy regimen used to treat colorectal cancer. It includes three medications: folinic acid, fluorouracil, and irinotecan. This combination works by interfering with the growth of cancer cells, slowing their spread in the body.
Cetuximab
is a targeted therapy used in the treatment of certain types of colorectal cancer. It works by blocking a protein on the surface of cancer cells, which can slow down or stop their growth.
Bevacizumab
is a medication that targets and inhibits a protein called vascular endothelial growth factor (VEGF). By blocking VEGF, bevacizumab helps prevent the growth of new blood vessels that tumors need to grow and spread.

What is already known about the treatment

Cetuximab
Cetuximab is administered intravenously and is used in the treatment of certain types of cancer, including metastatic colorectal cancer (mCRC). It is currently well-documented in medical literature and is often used in combination with chemotherapy. The main therapeutic indication for cetuximab is for patients with RAS/BRAF wild-type tumors. It works by targeting the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking their growth and survival. Cetuximab is classified as a monoclonal antibody.
Bevacizumab
Bevacizumab is given through an intravenous infusion and is used to treat various cancers, including metastatic colorectal cancer (mCRC). It is widely recognized in medical literature and is typically used alongside chemotherapy. The primary therapeutic indication for bevacizumab is for patients with RAS/BRAF mutations detected in liquid biopsy. It functions by inhibiting vascular endothelial growth factor (VEGF), which reduces the blood supply to tumors, slowing their growth. Bevacizumab is classified as an angiogenesis inhibitor.

Investigated diseases

Metastatic Colorectal Cancer (mCRC) – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs such as the liver or lungs. The disease can cause symptoms like changes in bowel habits, blood in the stool, and abdominal pain. As it advances, it may lead to more severe symptoms depending on the organs affected. The progression of mCRC can vary greatly among individuals, influenced by factors like genetic mutations and overall health.