WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)
Launched by MEDITERRANEAN INSTITUTE OF ONCOLOGY · May 13, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The WHOBI-STER clinical trial is studying the effects of two different treatments for patients with five or more brain metastases, which are cancer tumors that have spread to the brain from other parts of the body. The trial compares Stereotactic Radiosurgery (SRS), a targeted radiation therapy that focuses on the tumor while sparing healthy brain tissue, to Whole Brain Radiation Therapy (WBRT), which treats the entire brain. The main goal is to see how these treatments affect patients' thinking abilities, quality of life, and daily activities, as well as how well they control the cancer in the brain.
To be eligible for this trial, participants must be at least 18 years old, have a life expectancy of more than three months, and have at least five brain metastases confirmed by a doctor. Other requirements include having a good level of daily functioning and cognitive ability. If you join the study, you will receive either SRS or WBRT, depending on which group you are assigned to. The trial aims to enroll 100 patients over five years, and it has been approved by an ethics committee to ensure it is safe and ethical.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Mediterranean Institute Of Oncology
The Mediterranean Institute of Oncology (MIO) is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and cutting-edge research. With a multidisciplinary approach, MIO focuses on providing personalized treatment strategies that integrate the latest scientific discoveries with compassionate patient care. The institute is committed to enhancing the understanding of cancer biology and improving therapeutic outcomes by actively engaging in collaborative research initiatives and fostering partnerships with academic institutions and industry stakeholders. Through its robust clinical trial program, MIO aims to translate research findings into effective therapies, ultimately contributing to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Viagrande, Catania, Italy
Viagrande, Catania, Italy
Messina, , Italy
Palermo, , Italy
Patients applied
Trial Officials
Gianluca Ferini
Principal Investigator
REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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