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ID:52
Study Name:SOPRANO
Iras Number:1006425
Study Type:Interventional
Anatomical Region:Pelvis
Disease Site:Gynaecological
Study Status:Open
Site Location:
The Christie NHS Foundation Trust
Wilmslow Road, Manchester, M20 4BX
The Christie NHS Foundation Trust
Full Study Title:
Stereotactic radiotherapy alone or followed by Niraparib for oligometastases or oligoprogression in ovarian cancer following PARP inhibitor therapy
Research Summary:

SOPRANOĀ is a phase II clinical trial for people with certain types of advanced ovarian cancer (including ovarian, fallopian tube and primary peritoneal cancer). The study is testing whether a highly targeted form of radiotherapy—stereotactic body radiotherapy (SBRT)—either on its own or followed by a drug calledĀ niraparib, can delay the need for further treatment such as chemotherapy.

Some patients in the trial have cancer that has grown or spread to only a small number of places in the body (1–3). This is known asĀ oligoprogressionĀ orĀ oligometastatic disease.

Participants are randomly placed into one of two groups:

  • Group 1:Ā SBRT followed by niraparib
  • Group 2:Ā SBRT alone

Each group will include 21 patients.

About the Treatments

SBRT
SBRT delivers very precise, high‑dose radiotherapy directly to cancer cells while reducing exposure to healthy tissue.

Niraparib
Niraparib is a targeted cancer drug called a PARP inhibitor. It stops cancer cells from repairing themselves, which helps kill them. In this trial, researchers want to see if adding niraparib after SBRT helps the benefits of radiotherapy last longer.

What Participation Involves
  • All participants receiveĀ 3–8 SBRT treatmentsĀ over 5–19 days.
  • Those in Group 1 takeĀ daily niraparibĀ until their cancer worsens.
  • Everyone attends follow‑up appointments with scans and check‑upsĀ every 8 weeks in year one, thenĀ every 12 weeks in year two, and then as needed.
  • If a participant’s cancer later worsens in only 1–3 places again, more SBRT may be considered.Ā 
    Purpose of the Trial

The aim is to find out whether SBRT, with or without niraparib, can keep the cancer from progressing for at leastĀ 6 monthsĀ after starting treatment. If the results are promising, larger studies may follow. The findings will be shared with participants and published to support future research.

Contact Information:
If you have interest in this study, please discuss this with your oncology healthcare team.
Date Site Open:
APR
17
2025
Study End Date:
AUG
31
2026
āœ“ Randomisation
āœ“ Additional Appointments
Link to NIHR Database: Not provided