Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods. (STEREOMIC)

March 5, 2025 updated by: Gemelli Molise Hospital

STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa

The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.

Study Type

Observational

Enrollment (Estimated)

372

Contacts and Locations

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

Study Locations

  • Italy
    • Campania
      • Napoli, Campania, Italy
        • INT IRCCS Fondazione G. Pascale Napoli
    • Lombardia
      • Milano, Lombardia, Italy
        • IRCCS Ospedale San Raffaele
    • Molise
      • Campobasso, Molise, Italy, 80017
        • Responsible Research Hospital
    • Puglia
      • Taranto, Puglia, Italy
        • Presidio Ospedaliero "S. G. Moscati"

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Treatment with SRS/SRT techniques for a single secondary brain lesion
  • Availability of pre-RT brain MRI with contrast (1mm slice thickness)
  • Availability of CT simulation imaging for treatment
  • Availability of relevant clinical data in the medical record for the study's objectives
  • Follow-up of at least 6 months after the completion of SRS or SRT
  • Follow-up evaluation through brain MRI

Exclusion Criteria:

  • Age under 18 years
  • Lack of clinical/radiological data for the patient
  • Unavailability of the required imaging
  • Previous whole-brain radiotherapy treatment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a singular brain metastases
The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
Radiation: Stereotactic Body Radiotherapy/Radiosurgery
Stereotactic Body Radiotherapy/Radiosurgery
Other Names:
  • SBRT/SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity profile
Time Frame: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."
due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
Local control
Time Frame: We will evaluate Lc at one, two, and five years from the treatment
It will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area
We will evaluate Lc at one, two, and five years from the treatment

Collaborators and Investigators

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

Sponsor

Gemelli Molise Hospital

Investigators

  • Principal Investigator: Donato Pezzulla, M.D., Responsible Research Hospital

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)

February 20, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET20-02-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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