Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- audiogram
研究概览
简要总结
The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).
详细描述
Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.
Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vestibular schwannoma tumor size not more than 3 cm.
排除标准
- •NF 2 patient
- •underlying cerebrovascular disease
- •tumor compress and efface brain stem ( Koos 4)
结局指标
主要结局
audiogram
时间窗: two year
change from baseline audiogram at 6 months,1 year and 2 year
次要结局
- number of participant with adverse event(2 year)
- tumor size(2 year)
研究者
Putipun Puataweepong
Assistant professor
Ramathibodi Hospital