WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)

  • End date
    Sep 15, 2025
  • participants needed
  • sponsor
    Mediterranean Institute of Oncology
Updated on 25 May 2021


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 RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM 5, age 18 years, Karnofsky Performance Status (KPS) 70, life expectancy > 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments.

Condition Quality of life, Neurocognitive Deficit, quality-of-life, ADL
Treatment Stereotactic radiotherapy, Whole Brain Irradiation
Clinical Study IdentifierNCT04891471
SponsorMediterranean Institute of Oncology
Last Modified on25 May 2021


Yes No Not Sure

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
Hemorrhagic cerebral disease
Miliary metastases
Massive perilesional edema
Leptomeningeal involvement
Previous brain irradiation
Non-solid brain tumor
Ischaemic event
Alcohol and/or drugs abuse
Anxiety and depression
KPS 60
Life expectancy < 3 months
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