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.

N/AActive Not RecruitingNCT06869460

Gemelli Molise Hospital372 enrolled

Overview

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

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

372

Conditions

Brain Metastases Radiotherapy Side Effect

Interventions

Stereotactic Body Radiotherapy/RadiosurgeryRADIATION

Stereotactic Body Radiotherapy/Radiosurgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Presidio Ospedaliero "S. G. Moscati"

Taranto, Apulia, Italy

INT IRCCS Fondazione G. Pascale Napoli

Napoli, Campania, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Responsible Research Hospital

Campobasso, Molise, Italy

Outcomes

Primary Outcomes

Toxicity profile

"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."

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

Local control

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

Time frame: We will evaluate Lc at one, two, and five years from the treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.