Clinical Trials in Italy / NCT06869460
Active, not recruiting
Observational
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.
NCT06869460 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Brain MetastasesRadiotherapy Side Effect
Investigational drug(s) / intervention(s)
Stereotactic Body Radiotherapy/Radiosurgery
Stereotactic Body Radiotherapy/Radiosurgery: Stereotactic Body Radiotherapy/Radiosurgery
Study summary
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
Eligibility
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
Primary outcome measure(s)
- Toxicity profile — 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 — 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
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Presidio Ospedaliero "S. G. Moscati" | Taranto | Apulia | |
| INT IRCCS Fondazione G. Pascale Napoli | Naples | Campania | |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | |
| Responsible Research Hospital | Campobasso | Molise |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06869460 on ClinicalTrials.gov ↗ ← All trials in Italy