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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 : Not yet recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Information provided by (Responsible Party):
Gabriella Macchia, Gemelli Molise Hospital

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • 2-yr actuarial LC rate [ Time Frame: 2 years ]
    progression of disease inside SBRT field on a per lesion basis
  • 2-yr progression-free survival [ Time Frame: 2 years ]
    progression of disease out of SBRT field
  • 2-yr overall survival [ Time Frame: 2 years ]
    patient survival
  • treatment free interval [ Time Frame: 2 years ]
    time without any new treatment start after SBRT
  • rate of toxicity [ Time Frame: 2 years ]
    SBRT acute and late toxicity rate
  • 2-yr actuarial late toxicity free survival [ Time Frame: 2 years ]
    actuarial evaluation of late toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 13, 2020)
  • Radiomic clusters analysis [ Time Frame: 2 years ]
    Investigation of radiomic features for clustering analysis to predict response according to other histological and clinical parameters
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Oligometastatic Disease
  • Recurrent Ovary Cancer
  • Persistent
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: SBRT treatment
Intervention: Radiation: SBRT
Intervention: Radiation: Stereotactic body radiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriella Macchia, MD 0874 312259 macchiagabriella@gmail.com
Contact: Francesco Deodato, MD 0874 312258 francesco.deodato@gemellimolise.it
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04593381
Other Study ID Numbers  ICMJE CE 07-14-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gabriella Macchia, Gemelli Molise Hospital
Study Sponsor  ICMJE Gemelli Molise Hospital
Collaborators  ICMJE Fondazione Policlinico Universitario A. Gemelli, IRCCS
Investigators  ICMJE
Principal Investigator: Gabriella Macchia Radiotherapy Unit, Gemelli Molise
PRS Account Gemelli Molise Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP