RecruitingPHASE2INTERVENTIONAL

SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy

This study, called SOPRANO, is for women with ovarian cancer that has returned or started growing in one or a few small areas after they've been treated with a PARP inhibitor drug. Researchers want to see if a special type of targeted radiotherapy, called SBRT, can help. Some women will receive SBRT followed by the PARP inhibitor drug niraparib, while others will have SBRT alone. The main goal is to find out if this approach helps control the cancer and whether it's practical and acceptable for patients. This could allow women to continue with a similar type of treatment if their cancer has only progressed in a few spots, rather than having to switch to a completely new treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

20 Jun 2024

Estimated completion

30 Jun 2027

Ovarian Cancer Recurrent

What is this study about?

This study, called SOPRANO, is investigating a new way to treat ovarian, fallopian tube, or primary peritoneal cancer that has recurred. Sometimes, even when someone is taking a PARP inhibitor drug to manage their cancer, a few small areas of the cancer might start to grow or reappear. These are called 'oligometastases' (new, limited areas of cancer) or 'oligoprogression' (limited growth in existing cancer areas).

The idea behind this study is that these small areas of cancer growth might be slightly different from the rest of the cancer, making them resistant to the PARP inhibitor. If we can target and treat just these specific resistant spots with a focused type of radiotherapy called Stereotactic Body Radiotherapy (SBRT), it might allow other parts of the cancer, which are still responding to the PARP inhibitor, to remain under control. This could potentially help patients stay on their current treatment for longer, rather than needing to switch to a different, potentially more intensive, therapy.

The study will compare two approaches: some participants will receive SBRT followed by the drug niraparib (which is a type of PARP inhibitor), and others will receive SBRT alone. The researchers want to see if SBRT, either with or without niraparib, is effective in these situations and if it's a manageable and suitable treatment option for patients.

Key takeaways

Tests SBRT with or without niraparib for recurrent ovarian cancer.
For women with limited cancer growth (up to 3 spots) after PARP inhibitor use.
Aims to control cancer and allow continued targeted therapy.
Compares SBRT alone versus SBRT plus niraparib.
Involves targeted radiotherapy and potentially oral medication.
Participation includes regular check-ups and monitoring.

Who may be eligible?

This study is for women aged 18 or over who have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer. You would be considered if your cancer has shown signs of progression (growth or return) in a limited number of spots (up to three areas) while you were on, or shortly after finishing, a PARP inhibitor drug. It's important that this PARP inhibitor was your most recent treatment, and you must have taken it for at least six months.

The specific areas of cancer growth that are being targeted must be suitable for SBRT radiotherapy. Doctors will discuss this in a special meeting. You also need to be generally well, with a good ability to perform daily activities, and not have any medical conditions that would make it unsafe to receive SBRT or potentially restart a PARP inhibitor.

Key things that would mean you couldn't join include if you're planning surgery for your recurrent cancer, if your cancer progression is only shown by blood tests (like CA125) without visible lumps on scans, or if you are pregnant or could become pregnant and aren't using effective birth control.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Have you been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer?
Has your cancer shown growth in 3 or fewer spots after taking a PARP inhibitor for at least 6 months?
Is the PARP inhibitor the last cancer medicine you took?
Are you generally well and able to carry out daily activities?
Are you not currently pregnant and willing to use effective birth control if needed?

Answer every question to see your result.

What does participation involve?

If you join the SOPRANO study, you will first have a series of scans and tests to check your overall health and the cancer's location and size. You'll then be randomly assigned to one of two groups: one group will receive SBRT radiotherapy followed by the oral capsule niraparib, and the other group will receive SBRT alone. The SBRT treatment itself involves several visits to the hospital for the targeted radiation, usually over a short period.

If you are in the group receiving niraparib, you will take the capsules at home as prescribed. You will have regular follow-up appointments, including scans and blood tests, to monitor how you're doing and whether the treatment is working. This will continue until your doctor decides the treatment is no longer beneficial, or if you experience side effects that are too difficult to manage, or if you decide you no longer wish to participate. The total duration of your participation will vary depending on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a targeted treatment (SBRT) for limited cancer recurrence, potentially allowing you to continue with a PARP inhibitor-like treatment approach for longer. It could also help researchers learn more about managing recurrent ovarian cancer. However, like all medical treatments, there are potential risks and side effects associated with both SBRT and niraparib. These will be fully explained by the study team, and your health will be closely monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Western General Hospital
Verified postcode
Edinburgh, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting
University College London Hospitals
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is SBRT?

SBRT is a highly focused type of radiotherapy that delivers very precise, high doses of radiation to a small area, aiming to destroy cancer cells while minimising harm to healthy tissue.

What is a PARP inhibitor?

PARP inhibitors are a type of drug that targets a specific pathway in cancer cells, making it harder for them to repair themselves, ultimately leading to their death. Niraparib is one example.

What does 'oligometastatic' or 'oligoprogressive' mean?

These terms refer to a situation where cancer has only spread or grown in a very limited number of places (up to three spots), rather than widely throughout the body.

How long will the study last for me?

Your participation length depends on how you respond to treatment and other factors. You'll continue with treatment and follow-up until your doctors feel it's no longer benefiting you, or if you choose to stop.

Will I know which treatment group I'm in?

Yes, you will know whether you are receiving SBRT alone or SBRT followed by niraparib, as this is not a 'blinded' study.

How to find out more

Lorna Smith

soprano-icrctsu@icr.ac.uk +44 0203 437 6647 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.