SOPRANO Phase II Study of Stereotactic Radiotherapy With or Without Niraparib for Limited Ovarian Cancer Recurrence After PARP Inhibitor Treatment

What this Trial Is About

Researchers are evaluating the use of stereotactic radiotherapy SBRT alone or followed by the oral drug niraparib for women with ovarian, fallopian tube, or primary peritoneal cancer that has a limited number 3 or fewer of progressing or recurrent tumors after prior treatment with a PARP inhibitor. This phase II trial aims to assess the impact of these treatments on controlling cancer progression and to determine how feasible and acceptable SBRT is in this setting. Participants will be assigned to one of two groups one receiving SBRT followed by daily niraparib starting four weeks after SBRT, and the other receiving SBRT alone. SBRT treatment begins within 7 days of trial entry and is delivered in 3 to 8 sessions over 5 to 19 days, depending on tumor location. Niraparib doses are adjusted based on the participants weight and platelet count, continuing daily until disease progression or other reasons to stop treatment. During the study, participants will have regular disease assessments by CT or MRI scans every 8 weeks for the first year and every 12 weeks thereafter until progression. Researchers will monitor progression-free survival, overall survival, treatment side effects, quality of life, and other outcomes over up to 2 years. Safety and toxicity will be recorded, and participants may consent to future health data linkage for long-term tracking. The trial is expected to complete in late 2027.

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