Clinical trial · Interventional
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)
NCT04593381CI-TRIAL-00077411MITO-RT3/RADcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Disease | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT treatment
- description
- Intervention: Radiation: SBRT
- interventionNames
- Radiation: Stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Clinical complete response to SBRT by imaging
- timeFrame
- Assessment of Clinical complete response at six months
- description
- Radiologic response will be evaluated by morphological (contrast-enhanced CT scan and/or MRI) or functional imaging modalities (18F-fluorodeoxyglucose-PET) and classified according to the RECIST (version 1.1) or PERCIST criteria.
Secondary outcomes (6)
- measure
- 2-yr actuarial LC rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDMacchia G, Lazzari R, Colombo N, Laliscia C, Capelli G, D'Agostino GR, Deodato F, Maranzano E, Ippolito E, Ronchi S, Paiar F, Scorsetti M, Cilla S, Ingargiola R, Huscher A, Cerrotta AM, Fodor A, Vicenzi L, Russo D, Borghesi S, Perrucci E, Pignata S, Aristei C, Morganti AG, Scambia G, Valentini V, Jereczek-Fossa BA, Ferrandina G. A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups. Oncologist. 2020 Feb;25(2):e311-e320. doi: 10.1634/theoncologist.2019-0309. Epub 2019 Oct 10. PMID 32043791
- DERIVEDMacchia G, Pezzulla D, Campitelli M, Lucci S, Draghini L, Russo D, Fodor A, D'Agostino GR, Balcet V, Tamburo M, Giaccherini L, Tortoreto F, Augurio A, Ippolito E, Stefano AD, Fanelli M, Petrella L, Cilla S, Cosentino F, Marchetti C, Salutari V, Morganti AG, Gambacorta MA, Fagotti A, Pignata S, Scambia G, Ferrandina G, Deodato F. Treatment of Oligometastatic Parenchymal Lesions in Ovarian Cancer With Stereotactic Ablative Radiation Therapy: A Multicenter Prospective Phase 2 Trial (MITO RT3/RAD). Int J Radiat Oncol Biol Phys. 2025 Sep 1;123(1):228-237. doi: 10.1016/j.ijrobp.2025.03.032. Epub 2025 Mar 31. PMID 40174649
- DERIVEDMacchia G, Jereczek-Fossa BA, Lazzari R, Cerrotta A, Deodato F, Ippolito E, Aristei C, Gambacorta MA, Scambia G, Valentini V, Ferrandina G. Efficacy and safety of stereotactic body radiotherapy (SBRT) in oligometastatic/persistent/recurrent ovarian cancer: a prospective, multicenter phase II study (MITO-RT3/RAD). Int J Gynecol Cancer. 2022 Jul 4;32(7):939-943. doi: 10.1136/ijgc-2021-002709. PMID 34155084