Comparing whole brain irradiation and stereotactic radiosurgery for patients with multiple brain metastases
WHOle Brain Irradiation and STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER): a Prospective Comparative Study of Neurocognitive Outcomes, Level of Autonomy in Daily Activities and Quality of Life
NA · Mediterranean Institute of Oncology · NCT04891471
This study is testing whether a new type of targeted radiation therapy works better than traditional whole brain radiation for people with multiple brain tumors to see how it affects their thinking, daily activities, and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mediterranean Institute of Oncology (other) |
| Locations | 4 sites (Viagrande, Catania and 3 other locations) |
| Trial ID | NCT04891471 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the neurocognitive performance, daily activities, and quality of life in patients with five or more brain metastases from solid tumors. It compares the effectiveness of Stereotactic RadioSurgery (SRS) against Whole Brain RadioTherapy (WBRT) in a multicentric randomized controlled setting. The study aims to enroll 100 patients over five years, assessing their cognitive function and daily living activities before and after treatment. Participants will undergo SRS using advanced LINAC techniques, while the control group will receive WBRT.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with five or more brain metastases and a life expectancy of more than three months.
Not a fit: Patients with contraindications to SRS, significant cognitive impairment, or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with multiple brain metastases.
How similar studies have performed: Previous studies have shown promising results with SRS for brain metastases, suggesting potential benefits of this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Viagrande, Catania and 3 other locations
- Fondazione Istituto Oncologico del Mediterraneo — Viagrande, Catania, Italy (RECRUITING)
- REM Radiotherapy (parent company of Mediterranean Institute of Oncology) — Viagrande, Catania, Italy (RECRUITING)
- Radiation Oncology Unit - Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina — Messina, Italy (RECRUITING)
- Radiation Oncology, ARNAS-Civico Hospital — Palermo, Italy (RECRUITING)
Study contacts
- Principal investigator: Gianluca Ferini — REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
- Study coordinator: Gianluca Ferini
- Email: gianluca.ferini@grupposamed.com
- Phone: +393311341117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurocognitive Deficit, Quality of Life, Activities of Daily Living, multiple brain metastasis, neurocognitive decay, whole brain radiotherapy, stereotactic radiosurgery, stereotactic body radiotherapy