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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 372
- Locations
- 4
- Primary Endpoint
- Toxicity profile
Study Overview
Brief Summary
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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."
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
Secondary Outcomes
No secondary outcomes reported