Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
This study is for adults with advanced bowel cancer that has spread. We are investigating a treatment that combines two medicines, FOLFIRI and cetuximab. The main goal is to find out if giving this treatment with planned breaks is better than giving it continuously. We want to see if breaks lead to the disease staying under control for longer, mean people have a better quality of life, and experience fewer side effects. We're also using a new blood test to see if we can spot changes in the cancer before they show up on scans. This could help doctors react faster if the treatment needs to be restarted. This study compares these two ways of giving treatment to find the best approach for patients.
At a glance
What is this study about?
This study is designed for adults who have bowel cancer that has spread to other parts of the body, and for whom standard treatments haven't worked or aren't suitable. Specifically, it's for patients whose cancer cells have certain features (called RAS/BRAF wild-type). The treatment being studied is a combination of chemotherapy called FOLFIRI and a targeted drug called cetuximab. These medicines are already used to treat bowel cancer.
The main question we're trying to answer is whether giving these treatments with planned breaks is more effective or has fewer side effects than giving them continuously. We want to see if taking breaks can help patients manage their treatment better, improve their overall quality of life, and keep the cancer under control for a longer time. We'll be carefully comparing these two approaches.
Another important part of this study involves new blood tests. We're hoping these tests can tell us if the cancer is growing sooner than traditional scans. If we can detect changes earlier, doctors might be able to restart treatment more quickly, potentially helping patients even more. We will also be looking at how your treatment affects your daily life by asking you to fill out questionnaires about your quality of life.
Key takeaways
- A study for adults with advanced bowel cancer.
- Compares continuous treatment vs. treatment with planned breaks.
- Aims to improve quality of life and reduce side effects.
- Uses new blood tests to detect cancer changes earlier.
- Involves regular blood tests, scans, and questionnaires.
- Long-term follow-up for 3 years after treatment.
Who may be eligible?
For this study, we are looking for adults aged 18 or older who have advanced bowel cancer that has spread. Your cancer must have certain genetic features, called 'RAS/BRAF wild-type', which your doctor will check. It's important that your overall health is good enough to manage the treatment, meaning your body systems like blood, liver, and kidneys are working well.
You should also have had a diagnosis of bowel or rectal cancer that has spread and cannot be surgically removed. Your medical team will need to confirm these details from your existing health records and possibly some new tests.
You cannot take part if you have certain other serious health conditions or your body's systems are not functioning adequately. Your doctor will be able to tell you if you meet all the specific requirements for this study.
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 and doctors cannot operate on?
- Has your doctor confirmed your cancer has the 'RAS/BRAF wild-type' genes?
- Are your general health and organ functions (like blood, liver, kidneys) considered good enough for treatment?
- Are you able to provide agreement to join the study?
What does participation involve?
If you decide to take part in this study, you will receive treatment with FOLFIRI and cetuximab. This treatment will be given either continuously or with planned breaks, depending on which group you are randomly assigned to.
You will have regular check-ups, including blood tests every 4 weeks and imaging scans (like CT scans) every 12 weeks, to monitor your health and how the treatment is working. We will also ask you to fill out questionnaires to share how you are feeling and how the treatment is affecting your daily life.
Treatment will continue for as long as it is helping you and you are not experiencing severe side effects. After you finish the treatment part of the study, we will continue to follow your health for at least 3 years to understand the long-term effects of the treatment. The total length of your participation will depend on how you respond to treatment and the follow-up period.
Potential risks and benefits
Locations (1)
- Charite University, BerlinVerified postcodeBerlin, Germany
Common questions
What kind of cancer is this study for?
This study is for adults with advanced bowel cancer that has spread to other parts of the body.
What are FOLFIRI and cetuximab?
FOLFIRI is a type of chemotherapy, and cetuximab is a targeted drug that works by blocking signals that help cancer grow. Both are used to treat bowel cancer.
Why are you looking at giving breaks in treatment?
We want to see if taking planned breaks from treatment can lead to fewer side effects, better quality of life, and still keep the cancer under control effectively.
What is the new blood test for?
The new blood test aims to detect if the cancer is growing earlier than scans can, so doctors can react faster if treatment needs to be adjusted or restarted.
How long will I be in the study?
Your treatment will continue as long as it's helping you. After treatment, we'll follow your health for at least 3 years.
How to find out more
Arndt Stahler, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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