A study of radioembolisation with Therasphere and chemotherapy for bowel cancer that has spread to the liver (EPOCH)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Cancer spread to the liver

Colon cancer

Rectal cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

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:

whose cancer has continued to grow
who can’t have surgery to remove the cancer

More about this trial

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 radioactive Open a glossary item beads. These are also called microspheres. A radiologist 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:

find out if radioembolisation and chemotherapy is a safe treatment
find out if radioembolisation and chemotherapy works better than chemotherapy alone
learn more about the side effects

Who can enter

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:

have bowel cancer or rectal cancer (colorectal cancer)
have stable cancer in the area where it first started if you didn’t have surgery
have cancer that has spread to the liver and it isn’t possible to remove it with surgery
have had your first combination of chemotherapy for cancer spread to the liver, this included the chemotherapy drugs called oxaliplatin or irinotecan, but your cancer continued to grow
are suitable to have a second combination of chemotherapy that includes oxaliplatin or irinotecan
don’t have any other treatment to the liver planned
have cancer that the doctor can measure on a scan and you had the scan after you completed your first combination of chemotherapy
finished your first combination of chemotherapy at least 14 days before starting the chemotherapy in this study
have satisfactory blood test results
are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
are willing to use reliable contraception if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part
You cannot join this study if any of these apply.

Cancer related
You:

have had radiotherapy to the liver
have cancer in more than half of your liver
have had a targeted cancer drug in the 28 days before having radioembolisation
had treatment directly into the blood supply in the liver including chemo embolisation (TACE) or radioembolisation
have areas of cancer spread outside of the liver, apart from the lung if there are fewer than 5 tumours that measure less than 1cm across or in the lymph nodes
can’t have the type of chemotherapy used in the study for any reason
have side effects from past treatments that haven’t resolved unless they are mild or won’t cause problems when you start study treatment
have had treatment as part of a clinical trial in the 30 days before joining this study
have any other medical condition or mental health problem that means you can’t have the treatment in this study

Medical conditions
You:

have breathing problems or you have a lung condition called COPD
have liver damage called cirrhosis or you have a blockage in the main vein into your liver (the portal vein)
aren’t suitable to have a fine tube (catheter) put into a blood vessel in your groin as part of the radioembolisation treatment, for example you have a risk of bleeding or a problem with the way your blood clots
have a blockage or problem where the tube from the pancreas and bile duct come together
have a build up of fluid (ascites ) around your tummy unless it is a very small amount
are having dialysis
have severe diarrhoea
have a serious infection
have changes to the brain caused by severe liver damage and a build up of toxins that can cause symptoms such as confusion
have a serious infection that is not controlled, for example hepatitis B or hepatitis C

Other
You:

have a severe allergy or are intolerant to contrast dye or certain drugs such as morphine (narcotics)
are pregnant or breastfeeding

Trial design

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
chemotherapy and radioembolisation instead of the second cycle of chemotherapy

EPOCH diagram

Chemotherapy
Everyone will have one of the following combinations of chemotherapy:

FOLFOX
FOLFIRI

FOLFOX includes the drugs:

folinic acid
fluorouracil (5FU)
oxaliplatin

FOLFIRI includes the drugs:

folinic acid
fluorouracil
irinotecan

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 central line Open a glossary item 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 quality of life study Open a glossary item .

Hospital visits

You’ll see a doctor and have some tests before you can take part. These include:

physical examination
blood tests
CT scan or MRI scan
a planning angiogram to check the blood supply to your liver if you are having radioembolisation

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.

Side effects

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:

tiredness (fatigue)
tummy (abdominal) pain or bleeding
feeling or being sick
high temperature (fever)
changes to blood tests that show how the liver is working

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:

irritation in the stomach or intestine resulting in pain, feeling or being sick, ulcers or bleeding
swelling (inflammation) or scarring of the lungs resulting in shortness of breath

Some common side effects of chemotherapy include:

feeling or being sick
tiredness (fatigue)
bruising
skin rash
weight loss
constipation
tummy (abdominal pain)
fever
hand foot syndrome

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.

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