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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04593381
Recruitment Status : Not yet recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Information provided by (Responsible Party):
Gabriella Macchia, Gemelli Molise Hospital

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 Cancer Oligometastatic Disease Recurrent Ovary Cancer Persistent 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

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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)
Estimated Study Start Date : January 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

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.

Primary Outcome Measures :
  1. Clinical complete response to SBRT by imaging [ Time Frame: Assessment of Clinical complete response will be carried out every three months for two years. ]
    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

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT04593381

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Contact: Gabriella Macchia, MD 0874 312259
Contact: Francesco Deodato, MD 0874 312258

Sponsors and Collaborators
Gemelli Molise Hospital
Fondazione Policlinico Universitario A. Gemelli, IRCCS
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Principal Investigator: Gabriella Macchia Radiotherapy Unit, Gemelli Molise
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gabriella Macchia, Radiation Oncologist, Gemelli Molise Hospital Identifier: NCT04593381    
Other Study ID Numbers: CE 07-14-2020
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Ovary,Oligometastasis,Stereotactic body radiotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type