Status:
UNKNOWN
WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)
Lead Sponsor:
Mediterranean Institute of Oncology
Collaborating Sponsors:
University of Messina
University of Palermo
Conditions:
Neurocognitive Deficit
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic...
Eligibility Criteria
Inclusion
- Age \> 18
- Life expectancy \> 3 months
- Brain metastases number ≥ 5
- Primary tumor histologic diagnosis
- Complete Extracranial staging
- Montreal Cognitive Assessment ≥ 20/30
- Barthel Activities of Daily Living ≥ 90/100
- KPS ≥ 70
- Signed Informed Consent
Exclusion
- Brain-MRI contraindications
- Contraindications to SRS
- Pregnancy
- Hemorrhagic cerebral disease
- Miliary metastases
- Massive perilesional edema
- Leptomeningeal involvement
- Previous brain irradiation
- Dementia
- Non-solid brain tumor
- Ischaemic event
- Alcohol and/or drugs abuse
- Anxiety and depression
- KPS ≤ 60
- Life expectancy \< 3 months
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04891471
Start Date
September 15 2020
End Date
September 15 2025
Last Update
January 18 2023
Active Locations (4)
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1
Fondazione Istituto Oncologico del Mediterraneo
Viagrande, Catania, Italy, 95029
2
REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
Viagrande, Catania, Italy, 95029
3
Radiation Oncology Unit - Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina
Messina, Italy, 98125
4
Radiation Oncology, ARNAS-Civico Hospital
Palermo, Italy, 90127