SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
Trial Parameters
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Brief Summary
SOPRANO is a multi-centre, randomised phase II trial which aims to assess the impact of Stereotactic radiotherapy (SBRT) and continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥ 18 years of age. 2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. 3. Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is required to have been the patient's last systemic therapy. 4. Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease. 5. ≤3 lesions of progressive disease. 6. Each lesion to undergo SBRT \<4 cm axial diameter, and feasible for SBRT as discussed in the SOPRANO virtual MDT (vMDT) meeting. 7. Measurable disease by RECIST criteria v1.1, which can be accurately assessed at baseline by CT or MRI. Patients with CA125 progression in the absence of measurable disease will NOT be eligible. 8. No contra-indication to restarting a PARP inhibitor. 9. Patients for whom surgery for recurrent disease is not planned. 10. Adequate baseline organ function to allow SBRT to all relevant targets as