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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Neurocognitive changes detected through Moca Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Signed Informed Consent
排除标准
- •Brain-MRI contraindications
- •Contraindications to SRS
- •Pregnancy
- •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
- •Life expectancy < 3 months
结局指标
主要结局
Neurocognitive changes detected through Moca Score
时间窗: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Changes of Autonomy in daily activities detected through the Barthel Index
时间窗: Change from Baseline pre-Radiotherapy Barthel Index every three months after treatment through study completion, an average of 1 year
To assess how level of autonomy in activities of daily living changes after SRS/SBRT compared to WBI
Neurocognitive changes detected through Hopkins Verbal Learning Test - Revised
时间窗: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Change in quality of life detected though the EORTC QLQ-C15-PAL questionnaire
时间窗: Change from Baseline pre-Radiotherapy EORTC QLQ-C15-PAL questionnaire every three months after treatment through study completion, an average of 1 year
To assess how quality of life changes after SRS/SBRT compared to WBI
Change in quality of life detected though the BN-20 questionnaire
时间窗: Change from Baseline pre-Radiotherapy BN-20 questionnaire every three months after treatment through study completion, an average of 1 year
To assess how quality of life changes after SRS/SBRT compared to WBI
次要结局
- Overall Survival(after treatment completion through study completion, an average of 1 year)
- Re-treatment rate(after first treatment completion through study completion, an average of 1 year)
- Acute Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading(from treatment completion until three months later)
- Karnofsky Performance Status changing(after treatment completion through study completion, an average of 1 year)
- Time to local failure(every three months after treatment through study completion, an average of 1 year)
- Late Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading(from three months after treatment completion through study completion, an average of 1 year)