A study of high intensity focused ultrasound for cancer of the rectum
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at using high intensity focused ultrasound (HIFU) to treat cancer of the back passage (rectal cancer).
More about this trial
Doctors treat rectal cancer with:
- surgery
- chemotherapy
- radiotherapy
- or a combination of these
These treatments can cause significant side effects. And the cancer might come back. So researchers are looking for new treatments for rectal cancer.
High intensity focused ultrasound (HIFU) uses high frequency sound waves to kill cancer cells. It is already a treatment of prostate cancer. To have treatment the doctor puts a device (probe) into the back passage (rectum). This device delivers the sound waves to the prostate cancer.
Researchers think that doctors could use HIFU to treat rectal cancer. In this study you have HIFU to treat your rectal cancer before having surgery to remove it. The researchers will then examine the cancer tissue the surgeon removed.
You have HIFU to treat the rectal cancer in the same way as the men having it for prostate cancer.
The aims of the study are to find out:
- the best dose of HIFU to kill rectal cancer cells
- what are the side effects
- how it affects quality of life
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 of the following apply. You:
- have rectal cancer that can be removed by surgery without having any other treatment first
- can have an ultrasound of your cancer
- can have a general anaesthetic
- can have HIFU
- are fit and well but need help to look after yourself (performance status 0 to 3)
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have cancer that can’t be removed by surgery (locally advanced rectal cancer)
- have cancer that is less than 1cm away from a sensitive organ or structure such as a major blood vessel, stuck to the triangular bone at the end of your spine (sacrum), vagina, prostate or bladder
- have heart disease, lung disease or any other disease that can’t be controlled with medication
- have an infection in the area between your hips (pelvis)
- have any other medical or mental health condition that the doctor or research team think could affect you taking part
- are pregnant
Trial design
This is a phase 1 study. The team need 30 people to join.
Everyone has HIFU to treat their rectal cancer. You have the treatment between 7 days and 10 days before your surgery.
You go into hospital to have HIFU. You have it in the operating theatre using a general anaesthetic. The doctor puts a small device (probe) into your rectum to give the HIFU. The treatment can take several hours. You stay in hospital overnight and go home the next day.
Quality of life
You fill in a few questionnaires:
- before the HIFU treatment
- 2 days after treatment
- between 7 days and 10 days before surgery
- 30 days after surgery
The questions ask about:
- any side effects you might have from the treatment
- your general health
- what you are able to do
The study team mail the questionnaires to you with a stamped addressed envelope for their return.
Hospital visits
You see the doctor to have some tests before taking part in the study. These tests include:
- physical examination
- heart trace (
ECG 
) - MRI scan
You go into hospital overnight to have the HIFU treatment.
2 days after leaving hospital a member of the team will telephone.
You see the doctor between 7 days and 10 days before surgery for:
- a physical examination
- blood tests
Side effects
This is the first time researchers have used HIFU to treat rectal cancer. So we are not sure what the side effects might be.
The most serious possible side effect might be a hole (perforation) your rectum. This is because the HIFU treatment could damage the wall of the rectum.
Doctors use HIFU to treat people with prostate cancer. They put a device (probe) into the rectum to give the treatment. The side effects of this include:
- bleeding
- pain
- infection
You might also have flu like symptoms.
You might also have pain or discomfort in the back passage (rectum) for a few days after HIFU.
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
Mr Jamie Murphy
Supported by
Sonacare Medical
Imperial College London
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
