A trial looking at stereotactic radiotherapy and niraparib for ovarian cancer (SOPRANO)
Cancer type:
Status:
Phase:
This trial is looking at 
by itself and stereotactic radiotherapy followed by niraparib for ovarian cancer that has started to grow again.
It is open to women who have:
- ovarian cancer
- fallopian tube cancer
- primary peritoneal cancer
And:
- your cancer has started to grow again
- you were taking a
PARP inhibitor or the PARP inhibitor was the last treatment you had that reached your whole body (systemic treatment )
More about this trial
Niraparib is a called a PARP inhibitor. It works by stopping a protein called PARP from working. Cancer cells rely on PARP to keep the in their cells healthy, so they can continue to grow and divide. Stopping PARP from working can cause the cancer cells to die.
Doctors already use niraparib to treat early ovarian cancer or when it has come back after chemotherapy. Unfortunately, cancer can start to grow again in some people who take niraparib.
Researchers are looking for new ways to treat these people.
Stereotactic radiotherapy is also called SBRT, SABR or SRT. It gives radiotherapy from many different angles around the body. The beams meet at the cancer. This means the cancer receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.
We know from research that having a PARP inhibitor after having SBRT could help people with ovarian cancer that had started to grow again.
In this trial, half the people have SBRT by itself. And the other half take niraparib after having SBRT.
The aims of this trial are to find out:
- how long it takes for the cancer to start growing again after SBRT by itself and after SBRT followed by niraparib
- how long people live after having SBRT by itself and SBRT followed by niraparib
- more about the side effects of these treatments
- how these treatments affect
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:
- have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- have had a scan that shows your cancer has started to grow again while having treatment with a PARP inhibitor or after finishing treatment with a PARP inhibitor. The PARP inhibitor must be the last treatment you had that reached the whole body (
systemic treatment ). Your doctor will know about this. - have had at least 6 months of PARP inhibitor treatment either as the
first line course of treatment for your cancer, or as treatment for cancer that had come back - have 3 or fewer areas of cancer that are getting worse
- have areas of cancer that are big enough to be treated with stereotactic radiotherapy. The trial team will decide this.
- have areas of cancer that the doctor can measure
- are able to have PARP inhibitors again
- have satisfactory blood test results
- are fully active but might not be able to do heavy physical work (performance status 0 or 1)
- are able to take capsules and tablets
- have had a sample of tissue (
biopsy ) taken that the team can ask for and is suitable for them to use. If this isn’t available, you must be willing to have a fresh biopsy taken. - are willing to use reliable contraception during treatment and for a while after if there is any chance you could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer spread to the brain that is newly diagnosed or is getting worse and it cannot be treated with either surgery to remove as much as possible of the cancer or stereotactic radiotherapy. You can join if you had cancer spread to the brain that has been treated and has been stable for 6 months or more.
- are not able to have stereotactic radiotherapy. This could be because you have radiotherapy to, or near to, the area of cancer or because of a medical condition.
- have an experimental drug as part of another clinical trial within 4 weeks of joining the trial
- are due to have surgery for cancer that has come back
- have ongoing moderate to severe side effects from previous treatment. This is apart from hair loss or nerve damage caused by chemotherapy. Ask your doctor about this.
- have a
blockage in the bowel or symptoms of a bowel blockage within 6 weeks of joining the trial - have had another cancer that was active or needed treatment within the past 3 years apart from
non melanoma skin cancer - are pregnant or breastfeeding
- have any other medical conditions or mental health problems that could affect you taking part
Trial design
This is a phase 2 trial. The team need 42 people to take part.
It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor choose which group you are in. The 2 groups are:
- stereotactic radiotherapy followed by niraparib
- stereotactic radiotherapy by itself
How often and how many treatments of stereotactic radiotherapy (SBRT) you have depends on the location of the cancer. This could be between 3 treatments over 5 days to 8 treatments over 19 days. Your doctor will tell you how many treatments you are to have.
How long each treatment takes depends on which stereotactic radiotherapy machine your hospital uses. There are 2 different types:
Linear Accelerator (Linac)- robotic surgery system (
Cyberknife )
Each treatment using Linac takes between 20 and 30 minutes.
Each treatment using Cyberknife usually takes between 45 and 60 minutes. But it may take up to 90 minutes.
Niraparib is a tablet. You start niraparib 4 weeks after finishing the SBRT. Your doctor will tell you how many tablets to take. You take them once a day at the same time. You can have niraparib as long as it is helping and the side effects aren’t too bad.
Quality of life
You fill in questionnaires before you start SBRT and then at:
- 4 weeks after finishing SBRT
- 4 months after joining the trial
- 6 months
- 1 year
- and if your cancer starts to grow again
The questions ask about:
- your general health and wellbeing
- your daily activities
- side effects
These are quality of life questionnaires.
Samples for research
The team take blood samples:
- before starting SBRT
- after finishing SBRT
- during the trial follow up
Where possible they will take these samples when you have blood taken as part of your routine care. The team will tell you how often they will take the blood samples.
The team will ask if you are willing to give a fresh sample of cancer tissue (biopsy) if your cancer gets worse. They will only take these if you agree and it is safe to do so. You don’t have to agree to have this tissue sample taken. You can still take part in the trial.
The team use these samples to:
- find out more about the effects of having niraparib
- look for changes that might happen in the
genes
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- CT scan, MRI scan or PET-CT scan, if needed. Your doctor will tell you if it is needed and which scan you have.
Depending on where your cancer has spread to, you might have some other scans. Your doctor will tell you if this is the case and what the scans are.
You see the doctor or nurse after finishing the stereotactic radiotherapy. This is to see how you are and to ask if there are any side effects.
Follow up for people having niraparib after SBRT
You see the doctor 4 weeks after having the SBRT. This is for a physical examination and to see how you are. At this time, you also start niraparib.
You see the doctor every week for 4 weeks until they are happy with how you are. You then see the doctor every 8 weeks while you are taking niraparib.
You have a scan at 8 weeks and then:
- every 8 weeks for the first year
- then every 12 weeks for the second year
- and then as ordered by your doctor
You see the doctor when you stop taking niraparib. This is to see how you are and for blood tests.
Follow up for people having SBRT by itself
After having SBRT you see the doctor:
- at 4 weeks
- every 8 weeks for the first year
- every 12 weeks for the second year
You have a scan at 8 weeks and then:
- every 8 weeks for the first year
- every 12 weeks for the second year
- then as ordered by your doctor
Side effects
The trial 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 side effects of SBRT depend on which part of your body is being treated. Some side effects can happen in the first few weeks while having treatment. These include:
- tiredness
- shortness of breath and a dry cough
- feeling or being sick
- diarrhoea
- skin changes at the treatment area
- hair loss in the treatment area
- problems with swallowing or pain when swallowing
- your original cancer symptoms getting worse, but this is only for a short period of time
Your doctor will explain which of these side effects are likely to affect you.
Other side effects can happen many months or years after treatment. These side effects are called long term side effects.
We have more information about:
- niraparib and its side effects
- side effects of radiotherapy
- long term side effects of radiotherapy
Location
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
Professor Susana Banerjee
Supported by
Institute of Cancer Research (ICR)
GlaxoSmithKline (GSK)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
