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Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer (MITO-RT3/RAD)

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ClinicalTrials.gov Identifier: NCT04593381
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : September 27, 2022
Sponsor:
Collaborator:
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Information provided by (Responsible Party):
Gabriella Macchia, Gemelli Molise Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Recurrent Ovarian Carcinoma Oligometastatic Disease Radiation: Stereotactic body radiotherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SBRT treatment
Intervention: Radiation: SBRT
 Radiation: Stereotactic body radiotherapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 2-yr actuarial LC rate [ Time Frame: 2 years ]
    progression of disease inside SBRT field on a per lesion basis

  2. 2-yr progression-free survival [ Time Frame: 2 years ]
    progression of disease out of SBRT field

  3. 2-yr overall survival [ Time Frame: 2 years ]
    patient survival

  4. treatment free interval [ Time Frame: 2 years ]
    time without any new treatment start after SBRT

  5. rate of toxicity [ Time Frame: 2 years ]
    SBRT acute and late toxicity rate

  6. 2-yr actuarial late toxicity free survival [ Time Frame: 2 years ]
    actuarial evaluation of late toxicity


Other Outcome Measures:
  1. 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. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593381


Contacts
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Contact: Gabriella Macchia, MD 0874 312259 macchiagabriella@gmail.com
Contact: Francesco Deodato, MD 0874 312258 francesco.deodato@gemellimolise.it

Locations
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Italy
Gemelli Molise Hospital Recruiting
Campobasso, CB, Italy, 86100
Contact: Gabriella Macchia, MD    0874312261    studimito@libero.it   
Principal Investigator: Gabriella Macchia, MD         
S.C. di Radioterapia Oncologica-Azienda Sanitaria locale Recruiting
Biella, Italy
Contact: Vittoria Balcet, MD       Vittoria.Balcet@aslbi.piemonte.it   
Azienda sanitaria locale Lanciano Vasto Chieti Active, not recruiting
Chieti, Italy
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute Active, not recruiting
Milan, Italy
Campus Biomedico Active, not recruiting
Roma, Italy, 00100
Policlinico A. Gemelli, IRCCS Recruiting
Roma, Italy, 00100
Contact: Maura Campitelli, MD       maura.campitelli@policlinicogemelli.it   
Sub-Investigator: Gabriella Ferrandina, MD         
Università La Sapienza Active, not recruiting
Roma, Italy, 00100
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Radioterapia Recruiting
Udine, Italy
Contact: Francesca Titone, MD       francesca.titone@asufc.sanita.fvg.it   
Sponsors and Collaborators
Gemelli Molise Hospital
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Investigators
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Principal Investigator: Gabriella Macchia Radiotherapy Unit, Gemelli Molise
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gabriella Macchia, Radiation Oncologist, Gemelli Molise Hospital
ClinicalTrials.gov Identifier: NCT04593381    
Other Study ID Numbers: CE 07-14-2020
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriella Macchia, Gemelli Molise Hospital:
Oligometastasis
Stereotactic body radiotherapy
SBRT
SABR
Additional relevant MeSH terms:
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Ovarian Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders