Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer (NCT04593381) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer
Italy376 participantsStarted 2021-03-01
Plain-language summary
This is a prospective, multicenter, Phase II study aimed at defining the activity and safety of SBRT in MPR-OC. Clinical and imaging data as well as SBRT parameters would be analyzed with the aim to identify potential predictors of response to treatment and clinical outcome.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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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
What they're measuring
1
Clinical complete response to SBRT by imaging
Timeframe: Assessment of Clinical complete response at six months