
“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 the SonoTran Platform in combination with chemotherapy and a targeted drug. It is for people whose bowel cancer has spread to the liver.
Doctors can treat bowel cancer spread with chemotherapy and a . The chemotherapy drugs they can use include:
One of the targeted drugs they can use is cetuximab.
These drugs can help but researchers know that only a small amount of the drugs get into the cancer. So they are looking at ways to increase the amount of drugs that go into the cancer. They think that 2 new medical devices might help. The devices are designed to be used together. Together they are the SonoTran Platform.
The SonoTran Platform consists of the:
The SonoTran System is a specially designed ultrasound machine that is similar to an . It works by delivering special sound waves to a particular area of the body.
The SonoTran Particles are smaller than microscopic, cup shaped and have an air bubble inside the cup's cavity. When sound waves are directed at the particle the air bubble wobbles. The air bubble rapidly grows getting bigger until it bursts.
You have the SonoTran Particles as a drip into your vein. The doctor then uses the SonoTran System over the part of the body where the cancer is. The sound waves expand and shrink the SonoTran Particles. This rapid expanding and collapsing of the air bubbles can help pump more of the drugs into the cancer.
In this study researchers are looking at using the SonoTran Platform with irinotecan and 5FU (FOLFIRI) and cetuximab for bowel cancer that has spread to the liver.
There are 3 groups in this study. These are the:
The main aims of this study are to find:
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 groups in this study. The safety group has completed recruitment. There are some entry conditions that are the same for the performance group and efficacy group. And there are some entry conditions that are different for each group. |
Who can take part
Everyone
You may be able to join this study if all of the following apply. You:
Performance group
You may be able to join group 2 if all of the following also apply.
Efficacy group
You may be able to join group 3 if all of the following also apply.
Who can’t take part
You cannot join this study if any of these apply. You:
Performance group
You cannot join the performance group if you have a gene change (mutation) of the UGT-1A1 gene.
Efficacy group
You cannot join the efficacy group if any of these also apply. You:
There are 3 groups in this study.
Safety group
The safety group is now completed.
In this group the team found the amount of SonoTran Particles to give to use with the SonoTran System. They use this amount in the performance and efficacy groups.
Performance group
The study team needs 12 people to join the performance group.
You have an of your liver. This is to see where the cancer is in the liver. And to see whether the SonoTran can target the cancer spread. Depending on the results of the ultrasound you have either:
You have cetuximab, irinotecan and SonoTran Particles as a drip into a vein. While having the SonoTran Particles the doctor uses the SonoTran System over the liver. This takes about 40 minutes.
You have this treatment the day before surgery to remove the cancer that has spread to the liver.
Efficacy group
The study team needs 24 people to join the efficacy group.
:You have an of your liver. This is to see where the cancer is in the liver. And to see whether the SonoTran can target the cancer spread. Depending on the results of the ultrasound you have either:
You have FOLFIRI as a drip into a vein. This takes about 5 hours.
You then have the SonoTran Particles as a drip into a vein. While having the SonoTran Particles the doctor uses the SonoTran System over the liver. This takes about 40 minutes.
You have the SonoTran Platform treatment every 2 weeks with the chemotherapy.
As a part of FOLFIRI you then have 5FU over 46 hours at home. For this you have a pump. After 46 hours you go back to the hospital to have the pump disconnected.
You have FOLFIRI every 2 weeks. Each 2 week period is a . You have 6 cycles of treatment as part of the study.
Samples for research
You give blood samples as part of the study. Where possible the team take these when you have blood tests taken as part of your routine care.
The team take tissue samples as part of the study. They take the samples from the parts of the liver that the surgeon removes during surgery.
They use these samples to see how SonoTran is working.
Not everyone has the blood samples and tissue samples taken. Your doctor will tell you if this applies to you. They will also tell you when and how often you have them.
Performance and efficacy group
You see the doctor to have tests before taking part. These include:
You see the doctor at regular times during treatment. This is to see how you are and for blood tests.
Efficacy group
You have the following scans before treatment and twice more during treatment:
Follow up for performance group
About 4 weeks after the start of the study you see the doctor. This is:
Your doctor will then tell you how often they want to see you.
Follow up for efficacy group
About 2 weeks after you finish treatment you have:
You then see the doctor 3 months later. This is:
Your doctor will then tell you how often they want to see you.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The SonoTran Particles have not been used in people before this study. So the study team is still finding out what the side effects might be.
Based on animal studies possible side effects might include:
What happens to the SonoTran Particles?
The SonoTran Particles enter your bloodstream and travel through your blood circulatory system. They may wobble for up to an hour if they are activated by an ultrasound wave. They may stay in the body for a long time but are inactive on their own.
Animal studies have shown that these particles are taken up by specialist cells in the liver and rest there. A small number may end up outside of the liver. But the particles should not cause any problems in other parts of your body.
The team doesn’t expect the SonoTran Particles to cause the side effects of the chemotherapy drugs to be worse.
We have information on the side effects of:
Your doctor will talk to you about the possible side effects of all the treatments used in the study. They will answer any questions you might have.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Rachel Kerr
University of Oxford (sponsor)
NIHR Central Commissioning Facility
OxSonics Ltd
Oxford Clinical Trials Research Unit
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.”