
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is to see if adding radioembolisation to chemotherapy improves treatment for people whose bowel cancer has spread to the liver.
It is open to people who have finished their first combination of chemotherapy for cancer spread to the liver and:
Cancer spread to the liver is called advanced or metastatic bowel cancer. The usual treatment for bowel cancer that has spread is surgery and chemotherapy. But sometimes it isn’t possible for the doctor to remove the cancer. So you have chemotherapy to shrink or control the cancer. But it can continue to grow despite this.
Doctors are looking for new treatments that will help to control bowel cancer that has spread to the liver. In this study, they are looking at a treatment called radioembolisation.
TheraSphere is one product that doctors can use for radioembolisation. It uses millions of tiny glass beads. These are also called microspheres. A
injects the microspheres directly into the blood vessels near the cancer in the liver. The beads give off radiation directly to the liver.
The radiation damages the cancer cells and the cancer’s blood supply. As the beads only give off radiation to a small area, they cause little damage to the surrounding healthy tissue. This treatment is also called Selective Internal Radiation Therapy (SIRT).
In this study, everyone will have chemotherapy. However, some people also have a radioembolisation treatment in place of a cycle of chemotherapy.
The aims of the study are to:
The following bullet points list 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.
Who can take part
You may be able to join this study if all the following apply:
You:
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This phase 3 study is taking place worldwide. The study team need 420 people to take part including 130 from the UK.
It is a randomised study. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
Chemotherapy
Everyone will have one of the following combinations of chemotherapy:
FOLFOX includes the drugs:
FOLFIRI includes the drugs:
You have chemotherapy every 2 weeks. Each 2 week period is called a cycle of treatment. You have up to 6 cycles of treatment, lasting 12 weeks all together. You have all the drugs through a drip into a vein. You may have a put into a vein in your chest. If so, this will stay in place throughout your treatment.
You spend a few hours in hospital each time you have the drugs, but you have 5FU over 48 hours. You have it via a small pump which you can go home with. When the 5FU has finished you will need to go back to hospital to have the pump disconnected. It may be possible for the practice nurse at your GP surgery to do this, so you won’t need to go back to the hospital.
If you have access to funding of additional treatment, you might also have a targeted cancer drug such as bevacizumab, cetuximab or aflibercept. The study team can tell you more about this and how often you have it.
Radioembolisation
For people having radioembolistaion, you have a test up to look at the blood supply inside your liver before having the treatment. This is to reduce the risk of the microspheres affecting any other areas of your body. The doctor will inject a dye that shows up the blood vessels on a digital X-ray. Very rarely, people cannot have radioembolisation because they have too much blood flowing from the liver to the lungs. The tests take about 2 to 4 hours.
You have 1 radioembolisation treatment. You have this in place of the 2nd cycle of chemotherapy. The doctor makes a small cut in your groin and passes a fine tube (a catheter) from there up into blood vessels in the liver. The doctor then injects the microspheres through the catheter. The microspheres get stuck in the small blood vessels in and around the cancer. 2 weeks later you continue with chemotherapy and have the 3rd cycle.
You stop treatment if your cancer starts to grow again or the side effects are too bad. Your doctor will talk to you about other treatment options.
Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a .
You’ll see a doctor and have some tests before you can take part. These include:
You have your treatment at the hospital. You will need to stay overnight for 1 or 2 nights after having radioembolisation.
You have chemotherapy in the outpatient department so you shouldn’t need to stay overnight.
You see the study doctor every 4 to 8 weeks for a check up and blood tests. You also have a CT scan or MRI scan every 8 weeks.
Your will see the chemotherapy nurses in between these visits. They will see how you are getting on and ask about any side effects you might have.
As radioembolisation is a new treatment, there might be some side effects we don’t know about yet. The study team will give you a phone number to call if you are worried about anything. So far, the side effects we know about include:
It is possible that the microspheres may not reach or stay in the liver. They can then affect other parts of the body such as the stomach or lungs. This is very rare, but if it happens, it could cause:
Some common side effects of chemotherapy include:
Tingling and numbness in your hands or feet is a common side effect of oxaliplatin. Diarrhoea is a common side effect of irinotecan.
A common side effect of targeted cancer drugs such as bevacizumab is an allergic reaction to the infusion.
Your doctor will keep a close eye on you and treat any of these side effects straight away. The study doctor will talk to you about all the possible side effects before you agree to take part.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Ricky Sharma
Biocompatibles UK Ltd
For more information you can watch this video from the EPOCH study team.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”