Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE) AIO-KRK-0217.
This study, called CIRCULATE, is investigating a new way to decide on treatment for people with stage II bowel cancer (colon or rectal cancer). It uses a blood test called circulating tumour DNA (ctDNA) which can find tiny bits of cancer DNA in the blood. If this test shows cancer DNA, doctors are comparing whether giving chemotherapy (using the drug capecitabine) or simply monitoring them, leads to better long-term health. For those without cancer DNA detected, they are just being monitored. The main goal is to see if this personalised approach helps people stay cancer-free for longer and improves their overall health without unnecessary treatments.
At a glance
What is this study about?
This important study, known as CIRCULATE, is looking into how we can best treat people who have been diagnosed with stage II bowel cancer. Stage II means the cancer has grown through the wall of the bowel but hasn't spread to nearby lymph nodes or other parts of the body.
Currently, after surgery to remove the cancer, doctors sometimes suggest chemotherapy for stage II bowel cancer to reduce the chance of it coming back. However, not everyone needs this extra treatment, and chemotherapy can have side effects. This study aims to use a new, more precise approach. It uses a blood test called circulating tumour DNA (ctDNA) to look for tiny traces of cancer cells that might still be in the body after surgery. If the ctDNA test is positive, it means there's a higher chance the cancer could return.
The study wants to find out if using this ctDNA test can help doctors make better decisions about who needs chemotherapy and who doesn't. They are comparing giving chemotherapy (specifically with a drug called capecitabine) to people with positive ctDNA results against simply monitoring them closely. For those whose ctDNA test is negative, meaning no traces of cancer DNA were found, they will just be monitored. The main goal is to see if this personalised approach helps people stay free of cancer for longer and improves their overall health, while avoiding unnecessary chemotherapy for those who wouldn't benefit.
Key takeaways
- New study using a blood test (ctDNA) to guide treatment decisions for stage II bowel cancer.
- Compares chemotherapy to monitoring for patients with positive ctDNA.
- Aims to reduce unnecessary chemotherapy and improve long-term outcomes.
- Participants will either take chemotherapy tablets or be closely monitored.
- Involves regular check-ups and blood tests over several years.
Who may be eligible?
To take part in this study, you generally need to be an adult aged 18 or over. This study is specifically for people who have been diagnosed with stage II colon cancer or stage II rectal cancer.
The research team will have a full list of things they look for to confirm if someone is suitable. They need to make sure the study is right for you and that you meet all the health requirements to take part safely.
- Are you 18 years old or older?
- Have you been diagnosed with stage II colon or rectal cancer?
- Are you able to attend regular follow-up appointments?
- Are you generally well enough to potentially receive chemotherapy?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, the exact details of what you'll do will depend on your ctDNA test result and which group you are assigned to. Everyone will have blood tests, including the special ctDNA test.
If your ctDNA test is positive and you are in the chemotherapy group, you would receive the drug capecitabine. If you're in the monitoring group (either with a positive ctDNA or a negative ctDNA result), you would have regular check-ups and follow-up appointments. These check-ups will involve doctor visits and potentially scans or other tests to monitor your health. The study will follow you over a period of time to see how you're doing, looking at how long you stay cancer-free and your general health. The research team will explain the specific schedule of visits and tests to you in detail.
Potential risks and benefits
Locations (2)
- —Germany
- —Austria
Common questions
What is ctDNA?
ctDNA stands for circulating tumour DNA. It's a blood test that looks for tiny fragments of DNA that come from cancer cells floating in your bloodstream. It can help doctors see if any cancer cells might still be present after surgery.
What does 'stage II bowel cancer' mean?
Stage II bowel cancer means the cancer has grown beyond the inner layers of the bowel wall but has not spread to nearby lymph nodes or other organs. It's an important stage that often responds well to treatment.
What is Capecitabine?
Capecitabine is a chemotherapy drug, often given as tablets, used to treat some types of cancer, including bowel cancer. It works by stopping cancer cells from growing.
Will I definitely get chemotherapy if I join the study?
Not necessarily. If your ctDNA test is negative, you won't receive chemotherapy within the study. If your ctDNA test is positive, you might be put into a group that receives chemotherapy or a group that is closely monitored. This is done by chance, like flipping a coin.
How long will I be followed in this study?
The study aims to follow participants for several years to understand the long-term effects of the different treatment approaches on their health and whether their cancer returns.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.