Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
This study is for people who have had successful surgery or other treatments to remove all their bowel cancer that had spread. Researchers want to find out if giving a course of chemotherapy afterward helps keep the cancer from coming back and improves their overall quality of life. Half of the people will get chemotherapy, and the other half will have regular check-ups. The study will track how well both groups do over time. It's a 'Phase 3' study, meaning it's one of the final steps to see if a new treatment approach is better than what’s currently available.
At a glance
What is this study about?
Imagine you or someone you know has bowel cancer that has spread to other parts of the body, but doctors have been able to remove all of it with surgery or other procedures. This can be a huge relief, but there's always a worry the cancer might return. This study is designed to look into whether giving a course of chemotherapy *after* all visible cancer has been removed helps keep it away for longer.
The study aims to compare two approaches: one group will receive a type of chemotherapy (either mFOLFOXIRI or mFOLFOX-6) for up to six months. The other group will just have regular check-ups and monitoring to see if the cancer returns. By comparing these two groups, doctors hope to understand if the extra chemotherapy improves patients' health and quality of life without causing too many side effects.
This kind of research is really important because it helps doctors develop the best possible treatment plans for people with bowel cancer that has spread. They want to find out if this additional treatment can give people a better chance of staying cancer-free and living well.
Key takeaways
- The study is for people whose bowel cancer, which had spread, has now been fully removed.
- It compares extra chemotherapy after surgery to regular check-ups.
- You'll be randomly put into a group for treatment or follow-up.
- Participation involves regular scans, blood tests, and quality of life surveys for up to 5 years.
- The aim is to improve outcomes and quality of life for patients.
- Your general health and blood test results need to be within specific ranges.
Who may be eligible?
This study is for adults aged 18 or over. You would be considered if you have been diagnosed with bowel cancer that has spread, and all signs of the cancer have been successfully removed by surgery or other treatments. This clean-up of the cancer must have happened recently – within 3 to 10 weeks before joining the study.
It's important that you don't have any active bleeding or serious wound healing problems from your surgery when you join. Also, scans taken just before joining the study must show no remaining cancer. Your general health, including your blood test results for your kidneys, liver, and blood counts, needs to be within a healthy range to ensure you can safely receive any treatment.
Your doctor will check if you meet all the specific health requirements. For example, they'll look at how well your body processes certain medications, and your ability to carry out daily activities. These detailed checks are there to make sure the study is safe and appropriate 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?
- Have you had bowel cancer that spread, and has it all been taken out by surgery or other treatments in the last 3-10 weeks?
- Do your recent scans show no cancer remaining?
- Is your general health, including your blood counts and organ function, in a good state?
- Are you able to manage daily activities without too much difficulty?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups, a bit like flipping a coin. Two out of three people will be in the group that receives additional treatment, and one out of three will be in the group that has active follow-up.
If you're in the treatment group, you'll receive chemotherapy (either mFOLFOXIRI or mFOLFOX-6) for up to six months, with regular check-ups to monitor your health and any side effects. If you're in the other group, you'll have regular follow-up appointments and scans.
All participants will have regular visits for check-ups, blood tests, and scans (like CT or MRI) every three months for the first two years. After that, these checks will happen every six months for up to a total of five years. During your visits, you'll also be asked questions about how you're feeling and your quality of life. Sometimes, if the cancer returns, tissue samples might be collected again if possible.
Potential risks and benefits
Locations (79)
- Klinikum St. Marien AmbergVerified postcodeAmberg, Germany· Recruiting
- Helios Klinikum Bad SaarowVerified postcodeBad Saarow, Germany· Recruiting
- Klinikum BayreuthVerified postcodeBayreuth, Germany· Recruiting
- Charité Universitätsmedizin BerlinVerified postcodeBerlin, Germany· Recruiting
- Helios Klinikum Emil von BehringVerified postcodeBerlin, Germany· Recruiting
- MVZ Onkologischer Schwerpunkt am Oskar-Helene-HeimVerified postcodeBerlin, Germany· Recruiting
- Vivantes Klinikum am Urban BerlinVerified postcodeBerlin, Germany· Recruiting
- Vivantes Klinikum Spandau BerlinVerified postcodeBerlin, Germany· Recruiting
- St. Josef-Hospital BochumVerified postcodeBochum, Germany· Recruiting
- Johanniterkrankenhaus BonnVerified postcodeBonn, Germany· Recruiting
- Diakonie-Krankenhaus BremenVerified postcodeBremen, Germany· Withdrawn
- Klinikum ChemnitzVerified postcodeChemnitz, Germany· Recruiting
Common questions
What does 'metastatic colorectal cancer' mean?
It means bowel cancer that has spread from its original spot to other parts of your body.
What is the aim of this study?
The study wants to see if giving chemotherapy after all spread-out cancer has been removed helps to prevent it from coming back and improves your quality of life.
Will I definitely get chemotherapy if I join?
You'll be randomly assigned to one of two groups. Two out of three people will get chemotherapy, and one out of three will have regular check-ups.
How long will I be involved in the study?
The study involves regular check-ups and scans for up to five years. If you receive chemotherapy, that part of the treatment typically lasts up to six months.
What chemicals are in the chemotherapy treatments?
The chemotherapy treatments used are called mFOLFOXIRI or mFOLFOX-6. Your doctor can give you more detailed information about these medicines.
How to find out more
Dominik Modest, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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