A study to track bowel cancer cell DNA in the blood to predict whether cancer might return (TRACC)
Cancer type:
Status:
Phase:
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.
More about this trial
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:
- they can detect ctDNA in the blood
- they can use ctDNA to work out the risk of recurrence after surgery
- using ctDNA to decide whether chemotherapy is needed after surgery
- ctDNA can predict who is more likely to benefit from chemotherapy after surgery
Who can enter
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:
- newly diagnosed with bowel cancer and scans show that your cancer has not spread. Or you are suspected to have bowel cancer.
- due to have surgery with the aim to cure
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:
- have bowel cancer that has spread to the surrounding tissue and may have spread to nearby lymph nodes (stage 2 and stage 3). If you have stage 2 cancer it should be at a high risk of coming back. Your doctor will know about this.
- have had surgery to remove the cancer and there is a
clear margin. Your doctor will know about this. - have satisfactory blood test results
- have recovered well enough from surgery. Ask your doctor about this.
- are due to have chemotherapy within 12 weeks of your surgery
- can have a blood sample taken for the study after your surgery and be
randomised into a study group between 4 weeks and 10 weeks after surgery - can look after yourself, be up for half the day but not might be able to work (performance status 0, 1 or 2)
Who can’t take part
Part B
You cannot join Part B if any of these apply. You:
- are to have chemotherapy before surgery. You can join if you have cancer of the back passage (rectal cancer) and are to have
chemoradiotherapy before surgery. - are due to have radiotherapy after surgery
- have another cancer or had another cancer within the past 5 years. This is apart from successfully treated
non melanoma skin cancer , non muscle invasive bladder cancer, prostatic interepithelial neoplasm (PIN ), carcinoma in situ (CIS ) of the cervix or any other cancer that has not spread from the tissue where it started (non invasive cancer).
Part C
You cannot join Part C if any of these apply. You:
- have another cancer or had another cancer in the past 5 years. This is apart from non melanoma skin cancer and a carcinoma in situ (CIS).
- are not to have chemotherapy after surgery. This could be due to a major complication after surgery. Or for any other reason that your doctor thinks you shouldn’t have chemotherapy.
- are allergic or sensitive to the chemotherapy used in the study
- are to have the chemotherapy drug fluorouracil (5FU) as an
intravenous infusion either by itself or with another chemotherapy drug such as oxaliplatin
Trial design
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:
- not using ctDNA blood sample to start chemotherapy
- using ctDNA blood sample to start chemotherapy
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:
- capecitabine for 6 months or
- capecitabine and oxaliplatin (CAPOX) for 3 months
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:
- every 6 months for years 2 and 3 then
- once a year for years 4 and 5
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:
- your general health and wellbeing
- what daily activities you can do
- side effects and symptoms
- what other healthcare professionals you see or services you use such as your GP
These are quality of life questionnaires.
Hospital visits
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:
- every 3 months in the first year
- every 6 months in year 2 and 3
- every year in year 4 and 5
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.
Side effects
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.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor David Cunningham
Supported by
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
