
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This study is looking at using small pieces of the DNA of bowel cancer that circulate in the blood (ctDNA) to work out whether cancer might come back.
is made of
. Every cell has DNA including cancer cells. The cancer cells can shed small pieces of their DNA into the blood. This is
(or ctDNA).
This study is open to people with bowel cancer that has not spread to another part of the body and who are due to have surgery or have had surgery.
Surgery is one of the main treatments doctors use for bowel cancer. When they remove the cancer tissue they send it to the lab. Specialists in the lab look at the tissue to try and work out the risk of the cancer coming back (recurrence). If you have a high risk of recurrence your doctor suggests you have chemotherapy straight after surgery.
Using the tissue from surgery to work this out is not perfect. Researchers think that looking for ctDNA in the blood might be better.
The idea behind this is that when the cancer is removed there won’t be any ctDNA in the blood. This is because there are no cancer cells in the body shedding DNA.
They also think it might be a better way to find out whether the cancer has recurred.
Having a is the standard way to find out whether the cancer is coming back. But the team think that looking for ctDNA in the blood might show that the cancer is coming back before it shows up on a CT scan. And so you could start treatment earlier.
Chemotherapy has side effects. Doctors are concerned that some people are having chemotherapy when they may not need it. So researchers also want to find out if ctDNA can help doctors decide who needs chemotherapy and who doesn’t.
In this study you give regular blood samples for up to 5 years after surgery. The team look for ctDNA in the samples.
The aims of the study are to find out whether:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
There are 3 parts to this study. Part A is now complete. Part B and Part C are open to recruitment. There are different entry conditions for Part B and Part C. |
Who can take part
You can take part in the study if you are at least 18 years old.
Part B
You may be able to join Part B of this study if all of the following apply. You are:
To continue in the study after surgery there must be confirmation of the bowel cancer diagnosis.
Part C
You may be able to join Part C of this study if all of the following apply. You:
Who can’t take part
Part B
You cannot join Part B if any of these apply. You:
Part C
You cannot join Part C if any of these apply. You:
This study is in 3 parts.
Part A
Part A is now complete. It was a. The team found it was possible to do the study.
Part B
The study team need about 1,000 people to join Part B. You give several blood samples for up to 5 years. Where possible the team take these when you have bloods taken as part of your routine care.
You won’t get the results of the ctDNA test.
You might be able to join Part C of the study. Your doctor will talk to you about Part C if this the case for you. You will still be in Part B whether you agree to join Part C or not.
Part C
The team need 1,621 people to join this part.
Part C is randomised. A computer puts you into 1 of 2 groups. Neither you nor your doctor choose which group you are in. The 2 groups are:
After surgery everyone has a blood sample taken. The team uses this sample to look for ctDNA. They continue to take blood samples for up to 5 years. Where possible the team take these samples when you give blood as part of your routine care.
In part C, the you have is either:
Your doctor decides which you have based on factors such as the stage of your cancer and how fit and well you are.
Capecitabine is a tablet. Your doctor will tell you how many tablets to take and how often. You have oxaliplatin as a drip into a vein. Your doctor will tell you how often you have it.
Not using ctDNA
In this group you have the standard chemotherapy straight after surgery.
Using ctDNA
The treatment you have after surgery depends on whether the team find ctDNA in the blood sample after surgery. And what treatment your doctor planned for you to have after surgery.
They then continue to take blood samples every 3 months. The team will use these and CT scans to guide what treatment you have and when.
If ctDNA is found
If the team find ctDNA in the sample taken just after surgery this could mean there are cancer cells left in the body. In this case you start chemotherapy straight away. This is the standard treatment as planned by your doctor.
If ctDNA is not found
If the team don’t find ctDNA in the sample just after surgery this could mean there are no cancer cells left in the body. In this case whether you start chemotherapy and how much chemotherapy depends on what treatment your doctor planned for you after surgery.
After surgery if your doctor planned for you to have 2 chemotherapy drugs you will have 1 chemotherapy drug. But if your doctor planned for you to have 1 chemotherapy drug by itself then you don’t start chemotherapy.
At 3 months the doctor decides whether you start chemotherapy or increase it. This depends on whether there is ctDNA in the blood sample.
You might have a CT scan at 3 months. Your doctor will tell you if you need to.
The team take blood samples every 3 months for the first year and then:
Follow up in the trial
Everyone is followed up in the trial for up to 5 years. If a CT scan shows your cancer has comeback you are no longer followed up as part of the trial.
For people in the group whose treatment is guided by the ctDNA if the cancer comes back your doctor will talk to you about what are your treatment options.
Quality of life
In Part C you fill in questionnaires:
• when you are randomised into one of the groups
• at 3 months, 6 months, 9 months and 12 months in the first year
• then every 6 months in years 2 and 3
• then at the end of year 4
• and at the end of year 5
The questions ask about:
These are quality of life questionnaires.
Where possible, visits for the study are at the same time as the visits for your routine care. Following surgery, you might have blood tests about:
This might vary slightly depending on your situation.
The study team might ask you to have a CT scan after surgery. You don’t have to agree to have the scan taken.
The blood test to look for ctDNA is being investigated as part of this study. There is a risk that this could give incorrect results.
For example, there is a small risk that cancer cells are present, but the blood test does not detect ctDNA. The study team monitor you closely with further tests. If you do need chemotherapy, you will probably still start it within the recommended 12 weeks after surgery. But you may start later than usual. The study team will explain the risks and benefits in more detail.
The side effects of chemotherapy are the same, whether you are part of this study or not. We have information about the side effects of capecitabine and CAPOX. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Cunningham
The Royal Marsden NHS Foundation Trust
National Institute for Health Research (NIHR)
Guardant Health, Inc.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”