Department of Neurosurgery, Haukeland Universitetssjukehus, Bergen, Norway
Department of Medicine, University of Bergen, Bergen, Norway.
BMJ Open. 2021 Mar 17;11(3):e039396. doi: 10.1136/bmjopen-2020-039396.
The optimal management of small-sized to medium-sized vestibular schwannoma (VS) is a matter of controversy. Clinical results of the prevailing treatment modalities (microsurgery, stereotactic radiosurgery (SRS), and conservative management (CM)) are documented, but comparative studies are few, and none are randomised or blinded. Upfront radiosurgery, or a careful follow-up by MRI with subsequent treatment on growth, are two strategies used at many centres. The present study aims at comparing these strategies by randomising individuals with newly diagnosed tumours to either upfront SRS or initial CM.
The Vestibular Schwannoma: Radiosurgery or Expectation study is designed as a randomised, controlled, observer-blinded, single-centre superiority trial with two parallel groups. Eligible patients will be randomised using sequentially numbered opaque sealed envelopes, and the radiosurgery group will undergo standard Gamma Knife Radiosurgery (GKRS) within 2 months following randomisation. The primary endpoint is tumour growth measured as volume ratio V/V and volume doubling time, evaluated by annual T1 contrast MRI volumetric analysis. Secondary endpoints include symptom and sign development measured by clinical examination, audiovestibular tests, and by patient's responses to standardised validated questionnaires. In addition, the patient's working status, and the health economics involved with both strategies will be evaluated and compared. All outcome assessments will be performed by blinded observers. Power analysis indicates that 100 patients is sufficient to demonstrate the effect of GKRS on tumour volume.
The trial has ethical approval from the Regional Ethical Committee (23503) and funding from The Western Norway Regional Health Authority. Trial methods and results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines in a peer-reviewed journal.
Clinical trials: NCT02249572. Haukeland University Hospital record: 2014/314. Regional Ethical Committee (REC West): 23 503. The Western Norway Regional Health Authority: 912 281.
小型至中型前庭神经鞘瘤（VS）的最佳治疗方法存在争议。目前已经有关于主流治疗方法（显微手术、立体定向放射外科（SRS）和保守治疗（CM））的临床结果的记载，但比较性研究较少，且均无随机或盲法。许多中心采用的两种策略为：预先进行放射外科治疗，或在 MRI 上进行仔细的随访，然后根据肿瘤的生长情况进行治疗。本研究旨在通过将新诊断的肿瘤患者随机分为 upfront SRS 或初始 CM，比较这两种策略。
前庭神经鞘瘤：放射外科或期待治疗研究设计为一项随机、对照、观察者设盲、单中心优势试验，分为两组平行组。合格患者将使用连续编号的不透明密封信封进行随机分组，放射外科组将在随机分组后 2 个月内进行标准伽玛刀放射外科（GKRS）治疗。主要终点是通过每年 T1 对比 MRI 容积分析评估的肿瘤生长，测量指标为体积比 V/V 和体积倍增时间。次要终点包括通过临床检查、听前庭测试以及患者对标准化验证问卷的反应评估的症状和体征发展。此外，还将评估和比较两种策略的患者工作状态和涉及的健康经济学。所有结果评估均由盲法观察者进行。功效分析表明，100 例患者足以证明 GKRS 对肿瘤体积的影响。
该试验已获得地区伦理委员会（23503）和西挪威地区卫生当局的批准。试验方法和结果将按照《临床试验报告统一标准 2010》指南在同行评审期刊上进行报告。
临床试验：NCT02249572。Haukeland 大学医院记录：2014/314。地区伦理委员会（REC 西部）：23503。西挪威地区卫生当局：912 281。
