Study on Cetuximab, Irinotecan, and Fluorouracil for First-Line Treatment in Patients with Advanced Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for patients with advanced Colorectal Cancer. The treatment being tested includes a combination of medications: Cetuximab, Irinotecan, and Fluorouracil. These medications are used together as a first-line treatment, which means they are the initial treatment given for this type of cancer. The study is specifically looking at patients whose cancer has spread to other parts of the body, known as metastatic colorectal cancer, and who have certain genetic characteristics, such as being RAS wild-type and having the FcγRIIIA V/V genotype.

The purpose of the study is to evaluate whether this combination of medications is effective in treating this specific group of patients. Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor the patients over a period of time to see how well the treatment works and to observe any side effects. The study will also look at how long the treatment remains effective and the overall survival of the patients.

Throughout the study, the effectiveness of the treatment will be assessed using specific criteria to measure the size and growth of the cancer. The study will also track the duration of the patients’ response to the treatment, the time until the cancer progresses, and any toxic effects experienced. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with advanced colorectal cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

2 treatment initiation

The treatment begins with the administration of the medication regimen known as FOLFIRI combined with cetuximab. This involves receiving the medications through an infusion, which is a method of delivering drugs directly into the bloodstream over a set period.

3 medication details

The medications include cetuximab, folinic acid, fluorouracil, and irinotecan. Each is administered via infusion. The specific dosage and frequency are determined by the medical team based on individual patient needs and study protocols.

4 ongoing monitoring

Throughout the trial, regular monitoring is conducted to assess the patient’s response to the treatment. This includes physical examinations, blood tests, and imaging studies to evaluate the effectiveness and any side effects of the treatment.

5 response evaluation

The patient’s response to the treatment is evaluated using criteria known as RECIST version 1.1, which helps in measuring changes in tumor size and progression.

6 completion of treatment

The treatment continues until the study’s end date or until the medical team decides it is appropriate to stop. The estimated end date for the trial is May 20, 2026.

7 follow-up

After completing the treatment, follow-up visits may be scheduled to monitor long-term health and any lasting effects of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
Must be receiving FOLFIRI combined with Cetuximab as the first treatment for metastatic colorectal cancer. This means the cancer has spread to other parts of the body.
Must have a RAS wild-type tumor. This means the cancer does not have certain genetic mutations.
Must have the FcγRIIIa-158V/V genotype. This is a specific genetic characteristic.
Must be at Stage IV of cancer, indicating advanced cancer that has spread to other parts of the body.
If applicable, must have a negative pregnancy test to ensure they are not pregnant.
Must be younger than 75 years old.
Must have at least one measurable lesion, which is a tumor that can be measured in size, according to specific criteria called RECIST v1.1.
Must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Must have a life expectancy of more than 3 months.
Must provide written informed consent, which means they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who have a different type of cancer than colorectal cancer cannot participate.
Patients who do not have metastatic colorectal cancer cannot participate. This means the cancer has spread to other parts of the body.
Patients who do not have a specific genetic type called RAS wild-type cannot participate. This refers to a normal version of a gene that is not mutated.
Patients who do not have a specific genetic marker called FcγRIIIA V/V cannot participate. This is a specific version of a protein on the surface of certain immune cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Specialistica dei Colli – Ospedale Monaldi	Naples	Italy

Other Sites

Site Name	City	Country	Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
ASL Napoli 2 Nord – Ospedale Santa Maria delle Grazie	Pozzuoli	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	12.06.2019

Trial locations

Investigated drugs:

Cetuximab is a medication used in this trial to help treat advanced colorectal cancer. It works by targeting a specific protein on the surface of cancer cells, which can slow down or stop the growth of the cancer. This medication is often used in combination with other cancer treatments to improve their effectiveness.

Irinotecan is another medication involved in the trial. It is a type of chemotherapy that helps to kill cancer cells or stop them from growing and dividing. Irinotecan is used to treat colorectal cancer and is often given in combination with other drugs to enhance its cancer-fighting effects.

Fluorouracil is a chemotherapy drug used in this study to treat colorectal cancer. It works by interfering with the cancer cells’ ability to grow and multiply. This medication is commonly used in combination with other treatments to increase its effectiveness in fighting cancer.

Investigated diseases:

Colorectal cancer metastatic

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. The disease is often associated with changes in bowel habits, blood in the stool, and abdominal discomfort.

Trial ID:

2024-518987-11-00

NCT ID:

NCT03874026

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Cetuximab, Irinotecan, and Fluorouracil for First-Line Treatment in Patients with Advanced Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?