- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593381
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
Stereotactic Body Radiotherapy (SBRT) represents the cutting edge within high conformal and modulated radiotherapy techniques; it can provide high local control (LC) for curative-intent of low burden metastatic, persistent and metastatic lesions in face of minimal acute and late toxicities. SBRT is amenable even in patients who had already been managed by radiotherapy. In addition, SBRT has been shown to be active in chemoresistant disease, and potentially able to mount immune response through the release of tumor neoantigens after cell killing, thus allowing to synergize with immunotherapeutic approaches. SBRT has been widely adopted in the clinical setting of oligometastatic/persistent/recurrent (MPR) disease (up to <5 lesions) in several malignancies including also ovarian cancer (OC); the recently published retrospective, multicenter Italian study (MITO-RT1) has confirmed the activity and safety of SBRT in MPR OC, thus providing a model able to predict the higher chance of complete response of tumor lesions to SBRT, and local control rate.
The MITO-RT3/RAD trial is a prospective, Italian multicenter Phase II study aimed at evaluating the activity and safety of SBRT in MPR-OC patients. Clinical and imaging data, as well as SBRT technical parameters, would be analyzed with the aim to identify potential predictors of response to treatment and clinical outcome: in this context, additional insights into the tissue features of tumor lesions would be of clinical interest in the context of the personalized treatment, as testified by studies demonstrating that image-based quantitative features from pre-treatment imaging could predict clinical outcomes in several malignancies.
Furthermore, given the crucial role played by the mutational status of BRCA 1/2 genes in this disease, the assessment of BRCA gene status was considered mandatory, thus representing inclusion criteria.
The study will include patients with oligo-metastatic/persistent/recurrent lesions (MPR) from OC patients for which salvage surgery or other local therapies resulted not feasible, as per relative contraindication to further systemic therapy because of serious comorbidities, as per previous severe toxicity, unavailability of potentially active chemotherapy, or patient refusal of systemic therapy
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabriella Macchia, MD
- Phone Number: 0874 312259
- Email: macchiagabriella@gmail.com
Study Contact Backup
- Name: Francesco Deodato, MD
- Phone Number: 0874 312258
- Email: francesco.deodato@gemellimolise.it
Study Locations
-
-
-
Biella, Italy
- Recruiting
- S.C. di Radioterapia Oncologica-Azienda Sanitaria locale
-
Contact:
- Vittoria Balcet, MD
- Email: Vittoria.Balcet@aslbi.piemonte.it
-
Chieti, Italy
- Active, not recruiting
- Azienda sanitaria locale Lanciano Vasto Chieti
-
Milan, Italy
- Active, not recruiting
- Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
-
Roma, Italy, 00100
- Active, not recruiting
- Campus Biomedico
-
Roma, Italy, 00100
- Recruiting
- Policlinico A. Gemelli, IRCCS
-
Contact:
- Maura Campitelli, MD
- Email: maura.campitelli@policlinicogemelli.it
-
Sub-Investigator:
- Gabriella Ferrandina, MD
-
Roma, Italy, 00100
- Active, not recruiting
- Università La Sapienza
-
Udine, Italy
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Radioterapia
-
Contact:
- Francesca Titone, MD
- Email: francesca.titone@asufc.sanita.fvg.it
-
-
CB
-
Campobasso, CB, Italy, 86100
- Recruiting
- Gemelli Molise Hospital
-
Contact:
- Gabriella Macchia, MD
- Phone Number: 0874312261
- Email: studimito@libero.it
-
Principal Investigator:
- Gabriella Macchia, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBRT treatment
Intervention: Radiation: SBRT
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical complete response to SBRT by imaging
Time Frame: Assessment of Clinical complete response at six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-yr actuarial LC rate
Time Frame: 2 years
|
progression of disease inside SBRT field on a per lesion basis
|
2 years
|
2-yr progression-free survival
Time Frame: 2 years
|
progression of disease out of SBRT field
|
2 years
|
2-yr overall survival
Time Frame: 2 years
|
patient survival
|
2 years
|
treatment free interval
Time Frame: 2 years
|
time without any new treatment start after SBRT
|
2 years
|
rate of toxicity
Time Frame: 2 years
|
SBRT acute and late toxicity rate
|
2 years
|
2-yr actuarial late toxicity free survival
Time Frame: 2 years
|
actuarial evaluation of late toxicity
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiomic clusters analysis
Time Frame: 2 years
|
Investigation of radiomic features for clustering analysis to predict response according to other histological and clinical parameters
|
2 years
|
Breast cancer genes 1/2 (BRCA genes) characterization
Time Frame: 2 years
|
Investigation of the mutational status of BRCA 1/2 genes in this disease
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gabriella Macchia, Radiotherapy Unit, Gemelli Molise
Publications and helpful links
General Publications
- 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.
- Macchia 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE 07-14-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasms
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
-
Maastricht University Medical CenterVieCuri Medical Centre; Orbis Medical Centre; St.Jans Gasthuis Weert; Laurentius...TerminatedOvarian Cancer | Ovarian Carcinoma | Ovarian Cyst | Ovarian MassNetherlands
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Medical University of LublinCompletedOvarian Cancer | Unexplained Infertility | Borderline Ovarian Tumors | Benign Ovarian TumorPoland
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
Clinical Trials on Stereotactic body radiotherapy
-
Mercy ResearchCompletedNasopharyngeal Carcinoma | Squamous Cell Carcinoma of the Head and Neck | Salivary Gland Cancer | Paraganglioma of Head and Neck | Head and Neck Sarcoma | Chordoma of Head and Neck | Chondrosarcoma of Head and Neck | Angiofibroma of Head and NeckUnited States
-
The Netherlands Cancer InstituteCompletedLung Cancer | Metastatic Lung CancerNetherlands, United States, Canada, Germany
-
University of FloridaDiaCarta, Inc.Terminated
-
European Organisation for Research and Treatment...UnknownNon-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIGermany, Belgium, United Kingdom, Switzerland
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedNon-small-cell Lung CancerUnited States
-
Mayo ClinicActive, not recruitingProstate CancerUnited States
-
UMC UtrechtCompletedBone Metastases | Spinal MetastasesNetherlands
-
West China HospitalRecruitingProstate Cancer | Efficacy | Safety | Stereotactic Body Radiotherapy | High-riskChina
-
Sunnybrook Health Sciences CentreSt. Joseph's Healthcare Hamilton; The Ottawa Hospital; British Columbia Cancer... and other collaboratorsNot yet recruiting
-
University Health Network, TorontoRecruitingBreast Cancer Metastatic | Malignancy | Genito-urinaryCanada