NCT04593381Completed
Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer
Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer (MPR-OC): a Prospective, Multicenter Phase II Study (MITO-RT3/RAD)
Source: ClinicalTrials.gov · Last updated 23 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 376 (actual)
- First submitted
- 13 Oct 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Gemelli Molise Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT04593381
What you commit to
- Study type: Interventional
- Participants enrolled: 376
- From 1 Mar 2021 to the primary completion date, 31 Dec 2023
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous radiotherapy severe toxicity
Other illness
- co-morbidities and functional impairment considered clinically precluding the safe use of SBRT,
Other
- mucinous OC,
- borderline ovarian tumors,
- non-epithelial OC,
- pregnancy
- any psychological, sociological, or geographical issue potentially hampering compliance with the study,
- lesion diameter larger than 5 centimeters
Who the study is looking for
- 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\*
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| S.C. di Radioterapia Oncologica-Azienda Sanitaria locale Coordinator of this site? Confirm its status | Biella | Italy | Unknown status |
| Responsible Research Hospital Coordinator of this site? Confirm its status | Campobasso | Italy | Unknown status |
| Azienda Ospedaliera "Cannizzaro" Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda sanitaria locale Lanciano Vasto Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Ospedale Vito Fazzi Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Humanitas Clinical and Research Center-IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Policlinico A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Campus Biomedico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fatebenefratelli Isola Tiberina-Gemelli Isola, Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| S Maria Hospital Coordinator of this site? Confirm its status | Terni | Italy | Unknown status |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Radioterapia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.