AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized study to compare first-line treatment with either continuous or intermittent cetuximab plus FOLFIRI in patients with RAS/BRAF-wild-type metastatic colorectal cancer (mCRC): AIO-KRK-0524 / FIRE-11

This research study, called AIO-KRK-0524 / FIRE-11, is for people with a type of advanced bowel cancer that has spread (metastatic colorectal cancer) that doesn't have certain genetic changes (RAS/BRAF-wild-type). Doctors are comparing two ways of giving a medicine called cetuximab along with FOLFIRI chemotherapy. One group will receive cetuximab continuously, and the other will have breaks in their cetuximab treatment. The main goal is to see how long patients stay on a treatment strategy before treatment needs to change due to the cancer growing, serious side effects, or other reasons. They will also look at how patients feel and how long they live, aiming to find the best way to give these treatments.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

267

Start

20 Nov 2025

metastatic colorectal cancer

What is this study about?

This study is designed for individuals battling metastatic colorectal cancer, which means bowel cancer that has spread to other parts of the body. Specifically, it's for those whose cancer cells don't have certain genetic changes (called RAS/BRAF wild-type), as this can affect how well certain treatments work. You might have heard of some of these medicines: cetuximab, which targets specific proteins on cancer cells, and FOLFIRI, which is a combination of chemotherapy drugs including FOLINIC ACID, IRINOTECAN, and FLUOROURACIL.

The main aim of this study is to compare two different ways of giving cetuximab alongside FOLFIRI. One group of patients will receive cetuximab without any breaks, which is called continuous treatment. The other group will receive cetuximab with planned breaks, known as intermittent treatment. Doctors want to understand which approach is better in the long run. They'll be looking at something called 'Time to Failure of Strategy,' which basically measures how long a particular treatment plan works before it needs to be changed. This change could be because the cancer starts to grow, side effects become too strong, or other reasons.

Beyond simply how long a treatment lasts, the study will also explore other important aspects. This includes how long people live, how well the treatment shrinks the cancer, and how patients' quality of life is affected. They'll also be using advanced blood tests (called ctDNA analysis) to better understand the cancer's behaviour and how it responds to treatment, and to check for potential resistance. This research is important because it could help doctors find the most effective and tolerable way to treat this type of advanced bowel cancer, potentially improving outcomes and quality of life for patients in the future.

Key takeaways

This study compares two ways of giving cetuximab for advanced bowel cancer.
It's for patients whose cancer has spread (metastatic) and has specific genetic features (RAS/BRAF-wild-type).
Doctors are looking for the best timing of treatments – continuous or with breaks.
The study measures how long treatments work, side effects, and quality of life.
It uses advanced blood tests (ctDNA) to better understand cancer's response.
The goal is to improve treatment for this type of bowel cancer.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. It's open to both men and women.

Your doctors will need to confirm that your bowel cancer has spread to other parts of your body (metastatic) and that your cancer cells do not have specific genetic changes called RAS/BRAF mutations. This is important because the treatments being studied work best for this specific type of cancer.

There will also be other health checks to make sure you are well enough to safely participate in the study and receive the treatments. These will ensure the treatment is suitable 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 (metastatic colorectal cancer)?
Have tests shown that your cancer cells do not have RAS or BRAF mutations (RAS/BRAF-wild-type)?
Are you generally well enough to receive chemotherapy treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two treatment groups, meaning a computer will decide which treatment plan you receive. You will either get cetuximab continuously with your FOLFIRI chemotherapy, or you will get cetuximab with planned breaks. Both groups will receive the same medications, just in different patterns for the cetuximab. The treatments will be given over a period of time, and you'll have regular hospital visits for infusions (where the medicine is given into your vein), blood tests, and scans to monitor your health and how the cancer is responding. Doctors will also carefully track any side effects you might experience. They will also collect blood samples for special tests to monitor your cancer’s response to treatment using something called ctDNA. The total duration of your participation, including follow-up after your main treatment, will be discussed by your study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving close medical attention and access to potentially effective treatments for your condition. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy and targeted medicines. The study will monitor these risks very closely. You should always remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is FOLFIRI and Cetuximab?

FOLFIRI is a combination of medicines used to treat bowel cancer. Cetuximab is another type of drug that specifically targets cancer cells.

What does 'metastatic' mean?

Metastatic means that the cancer has spread from where it started in the bowel to other parts of your body.

What does 'RAS/BRAF-wild-type' mean?

This refers to specific genetic tests on your cancer. 'Wild-type' means your cancer cells don't have certain genetic changes (mutations) in the RAS or BRAF genes, which helps doctors know which treatments might work best for you.

Will I know which treatment group I'm in?

You will be randomly assigned to either continuous or intermittent cetuximab, meaning it's decided by chance. Your study team will explain which treatment plan you are on.

What is ctDNA analysis?

ctDNA analysis is a special blood test that looks for tiny pieces of cancer DNA in your blood to help doctors understand how your cancer is responding to treatment.