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

September 23, 2022 updated by: Gabriella Macchia, Gemelli Molise Hospital

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)

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Biella, Italy
      • 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
      • Roma, Italy, 00100
        • Active, not recruiting
        • Università La Sapienza
      • Udine, Italy
    • CB
      • Campobasso, CB, Italy, 86100
        • Recruiting
        • Gemelli Molise Hospital
        • Contact:
        • Principal Investigator:
          • Gabriella Macchia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gabriella Macchia, Radiotherapy Unit, Gemelli Molise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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