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 radiotherapyāstereotactic body radiotherapy (SBRT)āeither 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 (1ā3). 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 TreatmentsSBRT
SBRT delivers very precise, highādose 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.
- All participants receiveĀ 3ā8 SBRT treatmentsĀ over 5ā19 days.
- Those in Group 1 takeĀ daily niraparibĀ until their cancer worsens.
- Everyone attends followāup appointments with scans and checkāupsĀ every 8 weeks in year one, thenĀ every 12 weeks in year two, and then as needed.
- If a participantās cancer later worsens in only 1ā3 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.