A study of high intensity focused ultrasound for cancer of the rectum, vagina, cervix and endometrium
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 cancers that are in the area between the hips (pelvis).
It is open to people with one of the following cancers that has spread into the surrounding tissue or the lymph nodes (locally advanced):
More about this trial
Doctors can treat these cancers with:
- surgery
- chemotherapy
- radiotherapy
- immunotherapy
- or a combination of these
For some people:
- their cancer might come back (recur)
- the treatment might have stopped working and their cancer starts to grow again
- they might not be well enough to have any more of these treatments
So researchers are looking for new treatments for people in these situations.
High intensity focused ultrasound (HIFU) uses high frequency sound waves to kill cancer cells. It is already used in the treatment of prostate cancer. For this a device (probe) is put 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, vaginal cancer, cervical cancer and endometrial cancer.
The aims of this study are to find out:
- how well HIFU works for these cancers
- if HIFU can control the symptoms of these cancers
- if HIFU can help control pain caused by these cancers
- how it affects quality of life
Who can enter
You may be able to join this study if you have one of the following:
- rectal cancer
- vaginal cancer
- cervical cancer
- endometrial cancer
And all of the following apply. You
- have cancer that has spread into the surrounding tissue or lymph nodes (locally advanced)
- have cancer that cannot be removed by surgery
- have cancer in lymph nodes that can be treated with HIFU
- have cancer in a place where the HIFU device (probe) can reach
- 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 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 the spine (sacrum), vagina, prostate or bladder
- are already taking part in a trial or study that looks at symptom control (palliative care)
- 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 2 study. The team need 30 people to join.
Everyone has HIFU to treat their cancer.
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 questionnaires before the HIFU treatment and then after treatment at:
- 7 days
- 1 month
- 2 months
- 3 months
- then every 3 months for up to 2 years
The questions ask about:
- any side effects you might have from the treatment
- any symptoms from your cancer
- any pain you might have
- your general health
- what you are able to do
The study team mail out the questionnaires with a stamped addressed envelope for their return
Tissue and blood samples
The team will take some extra blood samples during the study.
They might ask for a tissue sample (biopsy) of your cancer after the HIFU treatment. They might also ask for a piece of cancer tissue from when you were first diagnosed.
They use these samples to find out how well the HIFU treatment has worked.
Hospital visits
You see the doctor to have some tests before taking part. These tests include:
- physical examination
- blood tests
- MRI scan
- heart trace (
ECG 
) - ultrasound
You see the doctor a week after treatment and then again at:
- 1 month
- 2 months
- 3 months
- then every 3 months for up to 2 years
You have an MRI scan a month after treatment.
Side effects
This is the first time researchers have used HIFU to treat these cancers. So we are not sure what the side effects might be.
The most serious possible side effect might be a hole (perforation) in 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 treatment. The side effects of this include:
- bleeding
- pain
- infection
You might also have flu like symptoms.
You might also have some pain or discomfort in the back passage (rectum) for a few days after.
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.
Supported by
Sonacare Medical
Imperial College London
Other information
Mr Jamie Murphy
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
