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RecruitingPhase IIInterventional

SOPRANO - Stereotactic radiotherapy alone or stereotactic radiotherapy follow by niraparib treatment for ovarian cancer with progressive disease in three or less lesions, or recurrence of 3 or less metastatic lesions that had previously achieved complete response.

Targeted medicines called PARP inhibitors can control ovarian, fallopian tube, or peritoneal cancer for long periods. However, cancer can sometimes return or grow in just one, two, or three small areas because a few cells have become resistant to the medication. The SOPRANO trial investigates whether using a precise, high-dose radiotherapy called stereotactic body radiotherapy (SBRT) can wipe out these few resistant spots. Participants receive SBRT, followed either by taking daily niraparib capsules or by close monitoring without additional medication. The main aim is to discover whether this targeted strategy keeps the cancer stable and delays the need to switch to chemotherapy. Taking part involves having regular scans, safety blood tests, and clinic check-ups. The findings could offer a gentler, more personalised treatment option for people whose cancer returns in only a few spots.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
Institute of Cancer Research Clinical Trial & Statistics Unit
Enrolment target
42
Start
01 Aug 2024
Estimated completion
31 Dec 2026

What is this study about?

When ovarian cancer returns or starts to grow again, it does not always spread widely. Sometimes, it only appears in one, two, or three small places. Doctors call this limited spread 'oligometastatic' or 'oligoprogressive' cancer. It usually happens because a tiny group of cancer cells has learned to resist drug treatments like PARP inhibitors, even though the rest of the body is still responding well.

The SOPRANO trial explores a new approach to managing this situation. Instead of immediately switching a patient onto traditional chemotherapy, doctors use high-precision radiotherapy known as SBRT. This technique directs concentrated radiation beams directly at the small tumours to destroy them, while sparing surrounding healthy tissues.

Researchers want to see if clearing these specific spots with SBRT—either on its own or followed by a daily maintenance drug called niraparib—can keep the disease under control for six months or longer. If this works, it could give patients more quality time before needing stronger treatments that often come with more difficult side effects.

Key takeaways

  • SOPRANO investigates targeted radiotherapy for ovarian cancer that has returned in three or fewer spots.
  • The trial aims to destroy resistant cancer spots and delay the need for chemotherapy.
  • Treatment involves pinpoint radiotherapy, followed either by daily niraparib capsules or standard monitoring.
  • Follow-up appointments and scans take place every 8 to 12 weeks to monitor your health.
  • Joining the study is voluntary, and you can withdraw at any time without changing your standard care.

Who may be eligible?

This trial is for women aged 18 and over who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer. To be considered, your cancer must have started growing again in no more than three distinct spots, with each spot measuring less than 4 centimetres across.

You must have previously taken a PARP inhibitor medicine for at least six months, and this must have been your most recent cancer treatment. You also need to be generally well enough to manage daily activities, have satisfactory blood and organ test results, and not have plans to undergo surgery for this cancer recurrence.

You will not be eligible if you are pregnant, if your cancer has spread to more than three areas, or if your tumours cannot be safely targeted with SBRT radiotherapy. Your hospital cancer team will review your scans and medical history to confirm whether this trial is suitable for you.

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.

  1. I am a woman aged 18 or over.
  2. I have ovarian, fallopian tube, or primary peritoneal cancer.
  3. My cancer has recently grown in three or fewer spots.
  4. I have previously taken a PARP inhibitor drug for at least 6 months as my last treatment.
  5. I am well enough to carry out light daily activities (ECOG score 0 or 1).
  6. I am not pregnant and surgery is not planned for my current tumours.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive SBRT radiotherapy delivered over three to eight short outpatient visits across one to three weeks. Depending on which group you join, you may also take a daily capsule of niraparib at home for as long as it continues to work. During the first year, you will visit the clinic every eight weeks for blood tests, health checks, and imaging scans (such as CT, MRI, or PET-CT) to see how well the treatment is working. In the second year onwards, these visits will reduce to every 12 weeks. Your GP will be kept updated throughout. You will remain on the trial until your cancer shows signs of growth, you experience troublesome side effects, or you choose to leave.

Potential risks and benefits

Taking part may help shrink your tumours and delay the need for chemotherapy, although direct personal benefit cannot be guaranteed. The results will also help doctors improve treatment for other women in the future. Radiotherapy can cause temporary side effects such as tiredness or skin irritation near the treated area. Taking niraparib can cause changes in your blood pressure and blood cell counts, which your care team will monitor closely with regular blood tests. Scans also involve small amounts of medical radiation. Taking part is entirely your choice, and you are free to leave the trial at any time without your routine NHS care being affected in any way.

Locations (7)

  • The Royal Marsden Hospital (sutton)
    City only
    Sutton, England
  • The Royal Marsden Hospital (london)
    Approximate
    London, England
  • The Christie
    Approximate
    Manchester, England
  • UCLH
    Approximate
    London, England
  • St. James's University Hospital
    Approximate
    Leeds, England
  • Western General Hospital
    Unverified
    Lothian, Scotland
  • Leicester Royal Infirmary
    Unverified
    Leicester, England

Common questions

What is SBRT?

SBRT stands for stereotactic body radiotherapy. It is an advanced treatment that delivers powerful, pinpoint doses of radiation straight to a tumour, protecting nearby healthy organs.

What is niraparib?

Niraparib is a targeted daily tablet known as a PARP inhibitor. It works by blocking cancer cells from repairing their DNA, which helps to stop them from multiplying.

Will taking part prevent me having chemotherapy later?

No. The goal of this trial is to delay the need for chemotherapy, but standard chemotherapy remains fully available to you in the future if your cancer progresses.

How often will I need hospital visits?

Radiotherapy takes place over several days across one to three weeks. After that, you will have check-ups and scans every eight weeks during the first year, reducing to every 12 weeks thereafter.

Do I have to pay for any trial treatments?

No. All study treatments, scans, and extra tests are provided free of charge through the clinical trial within the NHS.

How to find out more

Jessica Russell

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

Interested in taking part?

Register your interest

Share your details and the research team for "SOPRANO - Stereotactic radiotherapy alone or stereotactic ra…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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