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This study examines the effectiveness and safety of stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic, persistent or recurrent ovarian cancer. It enrolled patients over 18 with 1-5 lesions whose BRCA1/2 mutation status was assessed and for whom surgery or systemic therapy was not feasible. The study was conducted as a non-phase study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * diagnosis of ovarian cancer * age \>18 yrs, * ECOG performance status 0-3, * expected life expectancy \>6 months, * 1-5 synchronous lesions * any site of disease, * compulsory assessment of mutational status of BRCA1/2 genes (either germline or somatic), * salvage surgery or other local therapies not feasible, * relative contraindication to further systemic therapy because of serious comorbidities, * previous severe systemic therapy toxicity * unavailability of potentially active systemic therapy, * patient refusal of systemic therapy, * Re-treatment of lesions already treated with conventional external beam radiotherapy is allowed\* Exclusion Criteria: * mucinous OC, * borderline ovarian tumors, * non-epithelial OC, * previous radiotherapy severe toxicity * co-morbidities and functional impairment considered clinically precluding the safe use of SBRT, * pregnancy * any psychological, sociological, or geographical issue potentially hampering compliance with the study, * lesion diameter larger than 5 centimeters