Study on Cetuximab-Based Treatment for Metastatic Colorectal Cancer in Patients with RAS/BRAF Wild Type Tumors

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment plan for patients with metastatic colorectal cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The study involves a treatment regimen based on cetuximab, a medication that is a type of antibody designed to target cancer cells. The trial will explore how well this treatment works over three different stages of therapy in patients whose tumors have specific genetic characteristics, known as RAS/BRAF wild type.

Participants in the study will receive a combination of medications, including cetuximab, regorafenib, calcium levofolinate, bevacizumab, irinotecan, fluorouracil sodium, oxaliplatin, and Lonsurf (which contains trifluridine and tipiracil hydrochloride). These medications are administered in various forms, such as tablets or infusions, and work in different ways to help fight cancer. Some of these drugs are chemotherapy agents, which kill cancer cells, while others, like cetuximab and bevacizumab, are antibodies that target specific proteins on cancer cells.

The purpose of the study is to determine how effective this treatment plan is in controlling the cancer and to monitor any side effects that may occur. Participants will be monitored throughout the study to assess their response to the treatment and to ensure their safety. The study will also involve the use of a placebo in some cases to compare the effects of the active medications. The trial aims to provide valuable information on the best ways to treat metastatic colorectal cancer with these medications.

1 beginning of treatment

Upon joining the clinical trial, the treatment begins with the administration of cetuximab through an intravenous infusion. This means the medication is given directly into a vein. The frequency and dosage will be determined by the medical team based on individual needs and responses.

2 first line treatment

The first line of treatment includes a combination of medications. Fluorouracil sodium and oxaliplatin are administered via intravenous infusion. Calcium levofolinate is also given through an intravenous infusion to enhance the effects of fluorouracil.

This phase aims to assess the initial response to the treatment regimen. The duration and specific schedule will be provided by the healthcare team.

3 second line treatment

If the first line treatment is not effective, the second line treatment is initiated. This includes irinotecan and bevacizumab, both administered through intravenous infusion.

The medical team will monitor the response to this treatment and adjust as necessary. The schedule and dosage will be tailored to individual needs.

4 third line treatment

In cases where the second line treatment does not achieve the desired results, the third line treatment is considered. This involves the use of regorafenib, which is taken orally in the form of film-coated tablets.

The dosage and frequency will be determined by the healthcare team, and regular monitoring will be conducted to evaluate the effectiveness and safety of the treatment.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects. This includes blood tests and imaging studies as needed.

Follow-up visits are scheduled to ensure the safety and well-being of the patient, and to make any necessary adjustments to the treatment plan.

Who Can Join the Study?

Have a diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
Have signed an informed consent form before the screening process begins.
Have a diagnosis of metastatic disease, meaning the cancer has spread to other parts of the body.
Have RAS and BRAF wild-type status confirmed through a specific test of the primary colorectal cancer or related metastasis. This means certain genes in the cancer cells are not mutated.
Have a measurable disease according to specific criteria used to assess tumor size and response to treatment.
Be a male or female who is 18 years of age or older.
Have an ECOG Performance Status of 0 or 1, which indicates that the patient is fully active or has some symptoms but does not require bed rest during the day.
Have adequate function of the bone marrow, liver, and kidneys, as determined by specific medical tests conducted within 14 days before starting the study treatment.
If female and capable of becoming pregnant, have a negative pregnancy test result within 7 days before starting the study treatment.
If female and capable of becoming pregnant, or if male, agree to use adequate contraception during the study and for at least 3 months after the last dose of study treatment. This can include methods like abstinence, an intrauterine device, oral contraceptives, or a double-barrier method.

Who Cannot Join the Study?

Patients with any other type of cancer besides metastatic colorectal cancer cannot participate.
Patients who have a RAS/BRAF mutation in their cancer cells cannot participate. This means that their cancer has specific genetic changes that are not suitable for the study treatment.
Patients who are not starting their first line of treatment for metastatic colorectal cancer cannot participate. This means if they have already received other treatments for this condition, they are not eligible.
Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.

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 Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ospedale Vito Fazzi Lecce	Lecce	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
San Camillo Forlanini Hospital	Rome	Italy
ARNAS Garibaldi Di Catania	Catania	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
National Institute Of Gastroenterology Saverio De Bellis Research Hospital	Castellana Grotte	Italy
Fondazione Poliambulanza	Brescia	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Ospedale S G Moscati	Statte	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Oenxqehq Saezl cvvzw dr Gsqqa Fthaorumslpmlpmi &camjml Bfgxrstzg	Benevento	Italy
Ahpqjyw Ookgtgpuleq Rlrhfsauh San Cbmpp	Potenza	Italy
Omiadizy &pktsbiqq Pimrrqlsxjbzuv	Brindisi	Italy
Oozjaupp &iywshp Cezqdz Mubtm Pdisqufgbpsxpi Assvnp	Ragusa	Italy
Ikmhoj Iomppaeg Fjkmbqxnqjeiu Okodsjdkomi	Rome	Italy
Uvgplmgjce Miquk Ghooanz Ox Cttszyaok	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.01.2021

Trial locations

Investigated drugs:

Cetuximab is a medication used in this clinical trial. It is a type of therapy known as a monoclonal antibody. Cetuximab works by targeting specific proteins on the surface of cancer cells, which can help slow down or stop the growth of these cells. In this trial, cetuximab is being used to treat patients with a specific type of colorectal cancer that does not have certain genetic mutations, known as RAS/BRAF wild type. The goal is to see how effective and safe cetuximab is when used in combination with other treatments over three different stages of therapy.

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 or lungs. 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 nearby tissues and organs, and eventually enter the bloodstream or lymphatic system, allowing it to spread to distant sites. The progression of the disease can lead to symptoms such as changes in bowel habits, abdominal pain, and weight loss. The spread of cancer to other organs can cause additional symptoms depending on the affected area. The disease is often monitored through imaging tests and other evaluations to assess its spread and impact on the body.

Trial ID:

2024-518534-81-00

Protocol code:

CAPRI-2

NCT ID:

NCT05312398

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Cetuximab-Based Treatment for Metastatic Colorectal Cancer in Patients with RAS/BRAF Wild Type Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?