Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy
Trial Summary:
The SOPRANO Trial is a randomised, multi-centre phase II study that aims to evaluate the use of Stereotactic Body Radiotherapy (SBRT) with or without niraparib in patients with oligometastatic or oligoprogressive ovarian, fallopian tube, and primary peritoneal carcinoma following PARP inhibitor (PARPi) therapy. The trial seeks to determine whether this combination increases progression-free survival (PFS) at 6 months. Patients will be randomised into two cohorts: Cohort 1 will receive SBRT followed by niraparib, and Cohort 2 will receive SBRT alone. The primary endpoint is progression-free survival, while secondary endpoints include overall survival, time to first subsequent anti-cancer therapy, local control at the SBRT site, clinician-reported toxicity, and patient-reported quality of life (QoL). Exploratory endpoints include freedom from widespread metastatic disease and investigating potential mechanisms of PARP inhibitor resistance. The trial will also assess the feasibility and acceptability of delivering SBRT in this setting. A total of 42 patients will be recruited (21 per cohort), with follow-up assessments at 8 weeks post-randomisation, and then every 8 weeks in Year 1 and 12 weeks in Year 2 until disease progression.
RT QA Summary:
All QA activity will be streamlined with previous trial QA or SABR QA programmes, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | 2024 SABR QA Programme: FQ required |
| Outlining Benchmark Case | | All centres should already have ≥2 clinicians approved through streamlining or cascade training. Benchmark only if centre has <2 clinicians accredited (1 case per anatomical site) | |
| Planning Benchmark Case | | All centres should already be credentialed through streamlining. Benchmark only if centre has changed technique/equipment since (please discuss process with RTTQA contact) | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective contouring: All patients in the trial. Prospective planning: All patients in the trial. Retrospective: N/A |
| Data collection | | All patients | |
| Dosimetry Audit | | Lung audit: lung, bone and node only. Spine audit: lung, bone, node, spine, adrenal and liver. Subject to streamlining |
|
| QA Streamlining | | CtE, SEP, HALT, TRAP, SARON, STAR-TRAP, ATLANTA, STAMPEDE2, POINTER_PC. |
RTTQA Contact: enh-tr.sopranoqa@nhs.net
Chief Investigator: Professor Susana Banerjee
RT Lead: Dr Alexandra Taylor
Sponsor: Institute of Cancer Research SOPRANO-icrctsu@icr.ac.uk
Funder: GSK