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Ovarian NeoplasmsMITO-RT3/RADNCT04593381

Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer

A study testing Stereotactic body radiotherapy in people with Ovarian Neoplasms and Recurrent Ovarian Carcinoma, run by Gemelli Molise Hospital at 14 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
What is being tested?
Stereotactic body radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
14 sitesItaly
Study dates
1 Mar 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 13Show fewer
  • 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*

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Italy14 sites

  • S.C. di Radioterapia Oncologica-Azienda Sanitaria locale

    Biella

  • Responsible Research Hospital

    Campobasso, CB, 86100

  • Azienda Ospedaliera "Cannizzaro"

    Catania

  • Azienda sanitaria locale Lanciano Vasto Chieti

    Chieti

  • Ospedale Vito Fazzi

    Lecce, 73100

  • Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute

    Milan

  • Humanitas Clinical and Research Center-IRCCS

    Milan

  • Azienda USL - IRCCS di Reggio Emilia

    Reggio Emilia

  • Campus Biomedico

    Roma, 00100

  • Policlinico A. Gemelli, IRCCS

    Roma, 00100

  • Università La Sapienza

    Roma, 00100

  • Fatebenefratelli Isola Tiberina-Gemelli Isola,

    Roma

  • S Maria Hospital

    Terni

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Radioterapia

    Udine

Other trials in Italy

About this study

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)

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.

Read the 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

Being tested
Stereotactic body radiotherapy
Keywords
Oligometastasis, Stereotactic body radiotherapy, SBRT, SABR
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic body radiotherapyRadiation

    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 groups in NCT04593381
Study groupRoleWhat they receive
SBRT treatmentExperimentalIntervention: Radiation: SBRT
Receives: Radiation: Stereotactic body radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical complete response to SBRT by imaging

    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.

    Measured: Assessment of Clinical complete response at six months

Secondary outcomes (6)

  1. 2-yr actuarial LC rate

    progression of disease inside SBRT field on a per lesion basis

    Measured: 2 years

  2. 2-yr progression-free survival

    progression of disease out of SBRT field

    Measured: 2 years

  3. 2-yr overall survival

    patient survival

    Measured: 2 years

  4. treatment free interval

    time without any new treatment start after SBRT

    Measured: 2 years

  5. rate of toxicity

    SBRT acute and late toxicity rate

    Measured: 2 years

  6. 2-yr actuarial late toxicity free survival

    actuarial evaluation of late toxicity

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04593381
Sponsor's protocol ID
CE 07-14-2020
Acronym
MITO-RT3/RAD
Status last verified
May 2024
First submitted
13 Oct 2020
Last updated
23 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32043791

  • Macchia G, Pezzulla D, Campitelli M, Lucci S, Draghini L, Russo D, Fodor A, D'Agostino GR, Balcet V, Tamburo M, Giaccherini L, Tortoreto F, Augurio A, Ippolito E, Stefano AD, Fanelli M, Petrella L, Cilla S, Cosentino F, Marchetti C, Salutari V, Morganti AG, Gambacorta MA, Fagotti A, Pignata S, Scambia G, Ferrandina G, Deodato F. Treatment of Oligometastatic Parenchymal Lesions in Ovarian Cancer With Stereotactic Ablative Radiation Therapy: A Multicenter Prospective Phase 2 Trial (MITO RT3/RAD). Int J Radiat Oncol Biol Phys. 2025 Sep 1;123(1):228-237. doi: 10.1016/j.ijrobp.2025.03.032. Epub 2025 Mar 31.

    PubMed 40174649

  • 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.

    PubMed 34155084

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic body radiotherapy in people with Ovarian Neoplasms and Recurrent Ovarian Carcinoma, run by Gemelli Molise Hospital at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical complete response to SBRT by imaging (time frame: Assessment of Clinical complete response at six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593381, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

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