Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer
MITO-RT3/RAD
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)
1 other identifier
interventional
376
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 23, 2024
May 1, 2024
2.8 years
October 13, 2020
May 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical complete response to SBRT by imaging
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.
Assessment of Clinical complete response at six months
Secondary Outcomes (6)
2-yr actuarial LC rate
2 years
2-yr progression-free survival
2 years
2-yr overall survival
2 years
treatment free interval
2 years
rate of toxicity
2 years
- +1 more secondary outcomes
Other Outcomes (2)
Radiomic clusters analysis
2 years
Breast cancer genes 1/2 (BRCA genes) characterization
2 years
Study Arms (1)
SBRT treatment
EXPERIMENTALIntervention: Radiation: SBRT
Interventions
All patients accrued will be treated with SBRT to all sites of active metastatic disease as per CT scan or PET/CT and/or MRI. A range of schedules and doses are provided, it is advised that the maximum dose that can be achieved whilst meeting the organs at risk planning constraints is prescribed.
Eligibility Criteria
You may qualify if:
- diagnosis of ovarian cancer
- age \>18 yrs,
- ECOG performance status 0-3,
- expected life expectancy \>6 months,
- 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\*
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Responsible Research Hospital
Campobasso, CB, 86100, Italy
S.C. di Radioterapia Oncologica-Azienda Sanitaria locale
Biella, Italy
Azienda Ospedaliera "Cannizzaro"
Catania, Italy
Azienda sanitaria locale Lanciano Vasto Chieti
Chieti, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Milan, Italy
Humanitas Clinical and Research Center-IRCCS
Milan, Italy
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia, Italy
Campus Biomedico
Roma, 00100, Italy
Policlinico A. Gemelli, IRCCS
Roma, 00100, Italy
Università La Sapienza
Roma, 00100, Italy
Fatebenefratelli Isola Tiberina-Gemelli Isola,
Roma, Italy
S Maria Hospital
Terni, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Radioterapia
Udine, Italy
Related Publications (3)
Macchia 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: 32043791BACKGROUNDMacchia 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: 40174649DERIVEDMacchia 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: 34155084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriella Macchia
Radiotherapy Unit, Gemelli Molise
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
October 13, 2020
First Posted
October 20, 2020
Study Start
March 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
May 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share