NCT06869460

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 11, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

February 20, 2025

Last Update Submit

March 5, 2025

Conditions

Brain MetastasesRadiotherapy Side Effect

Keywords

Brain metastasesRadiotherapyStereotactic Body RadiotherapyRadiosurgeryRadionecrosisLocal ControlSafety profileRadiomics

Outcome Measures

Primary Outcomes (2)

  • 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."

    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

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

Study Arms (1)

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

Interventions

Stereotactic Body Radiotherapy/RadiosurgeryRADIATION

Stereotactic Body Radiotherapy/Radiosurgery

Also known as: SBRT/SRS
Patients with a singular brain metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Presidio Ospedaliero "S. G. Moscati"

Taranto, Apulia, Italy

Location

INT IRCCS Fondazione G. Pascale Napoli

Napoli, Campania, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Location

Responsible Research Hospital

Campobasso, Molise, 80017, Italy

Location

MeSH Terms

Conditions

Brain NeoplasmsRadiation Injuries

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Donato Pezzulla, M.D.

    Responsible Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 11, 2025

Study Start

February 20, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 11, 2025

Record last verified: 2025-02

Locations

IT(4)