Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Multicenter, open-label, randomized, 2-arm, phase II study to evaluate the efficacy and safety of cetuximab plus irinotecan rechallenge compared with investigator's choice of therapy in the third-line setting in ctDNA genomically selected patients with metastatic colorectal cancer (CITRIC Study)

This research study is for people in the UK with advanced bowel cancer that has spread to other parts of the body, and whose previous treatments haven't worked. Doctors are testing a new approach called 'cetuximab and irinotecan rechallenge', which means using these two drugs again after a break. This treatment will be compared against other standard treatments chosen by the patient's doctor. The main goal is to find out if the cetuximab and irinotecan combination shrinks the tumours more effectively than standard care. The study will also look at how safe the treatments are and how long patients live. Researchers are focusing on patients whose cancer has certain genetic features that might make them respond better to the study drug. This is an important step in finding better treatments for advanced bowel cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Associacio Per A La Recerca Oncologica

Enrolment target

Start

25 Oct 2024

metastatic colorectal cancer

What is this study about?

This study is designed for individuals in the UK living with advanced bowel cancer, also known as metastatic colorectal cancer. This means the cancer has spread from its original site to other parts of the body. If you've already had at least two different types of treatment for your cancer, and it has unfortunately progressed, this study might be relevant to you.

The main purpose of this research is to see if a specific treatment combination – cetuximab plus irinotecan – works better than other standard treatments. 'Rechallenge' means using these drugs again, potentially in patients who responded to them before. Researchers are particularly interested in patients whose cancer has certain genetic characteristics, found by a special blood test called a ctDNA test. They believe these genetic markers might help predict which patients will benefit most from this specific treatment.

The study will involve two groups of patients. One group will receive the cetuximab and irinotecan combination, and the other group will receive a treatment chosen by their doctor based on what's best for them. By comparing these two groups, doctors hope to learn if the cetuximab and irinotecan approach shrinks tumours more often and helps patients live longer, while also carefully monitoring any side effects. This research is an important step in finding more effective and targeted treatments for advanced bowel cancer.

Key takeaways

This study is for people with advanced bowel cancer that has spread.
It tests a specific drug combination (cetuximab + irinotecan) against standard care.
Patients are chosen based on genetic markers found in a blood test.
The main goal is to see if the drug combination shrinks tumours more effectively.
All treatment and follow-up will be carefully monitored by doctors.
You can stop participating at any time.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years or older, and male or female. You must have advanced bowel cancer that has spread to other parts of your body, and your cancer must have continued to grow despite having received at least two previous lines of treatment.

A key part of deciding if you can join is a special blood test called a 'ctDNA' test. This test looks for specific genetic features in your cancer cells. The study is designed for people whose cancer has particular genetic markers that researchers believe might respond better to the combination of cetuximab and irinotecan. More detailed medical checks will be done by the study doctors to make sure it's safe and appropriate for you to take part.

There will also be specific health requirements, for example, your general health, organ function, and previous treatments will all be carefully reviewed by the study team. They will also look at other medical conditions you might have to ensure the study treatment is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have bowel cancer that has spread to other parts of your body?
Have you had at least two previous treatments for your advanced bowel cancer?
Are you generally well enough to take part in a clinical trial?
Have you had a ctDNA test that shows specific gene changes in your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. Once confirmed, you would be randomly assigned to one of two groups: either the group receiving cetuximab and irinotecan, or the group receiving another treatment chosen by your doctor. This is like flipping a coin for fairness.

Throughout the study, you would have regular hospital visits for treatment, blood tests, scans (like CT scans) to check your cancer, and physical examinations. These visits help the study team monitor how well the treatment is working and check for any side effects. The exact number and frequency of visits will be explained to you by the study team.

You will continue treatment for as long as it is helping you and you are not experiencing severe side effects. The study will closely follow you until your cancer progresses, you choose to stop treatment, significant side effects occur, or in the case of death. Even if you stop treatment, the doctors will continue to follow your health for a period of time.

Potential risks and benefits

Taking part in a clinical trial may offer certain potential benefits, such as receiving a new and potentially effective treatment that is not yet widely available, and closely monitored medical care. However, like all medical treatments, both the study drugs and standard treatments carry potential risks and side effects. These can vary widely, from mild discomfort to more serious reactions. You will be given a detailed explanation of all known or potential risks before you decide to join. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is 'advanced bowel cancer'?

Advanced bowel cancer means the cancer has spread from your bowel to other parts of your body. Doctors sometimes call this 'metastatic' cancer.

What are cetuximab and irinotecan?

These are specific chemotherapy drugs used to treat bowel cancer. Cetuximab is a targeted therapy aiming at specific cancer cell features, and irinotecan is a standard chemotherapy drug.

What does 'ctDNA genomically selected' mean?

It means the study is looking for particular genetic markers in your cancer células, found through a blood test. These markers might help predict if you'll respond better to the study treatment.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It mainly focuses on whether a new treatment works and is safe, often in a smaller group of people, before larger studies begin.

Will I definitely get the new treatment?

No, because this is a 'randomised' study, you will be randomly assigned to either receive the cetuximab and irinotecan combination or a standard treatment chosen by your doctor. It's like flipping a coin.