Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- The numbers of participants with preserve hearing
研究概览
简要总结
The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. Recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients.
The main objective of this study is to evaluate if GKRS can inhibit progression of hearing loss in patients with VS. Patients with preserved hearing will be offered to participate in the study and randomized ether to GKRS or initial conservative treatment for their vestibular schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and audiometry and evaluated after one, three and five years after treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly (<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
- •Vestibular schwannoma with or without evidence of growth.
- •Patients between 18 and 80 years of age.
- •Karnofsky performance score >70
- •Patients with vestibular schwannoma and preserved hearing according to Gardner Robertson class 1-2, and speech discrimination (SD) scores between 50-100% will participate in the hearing preservation part of the study.
排除标准
- •Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.
- •Patients who had other treatments prior to the GKRS (usually microsurgery (MS), GKRS or external beam radiation) for their tumour will also be excluded for the same reason.
- •Patients who are not citizens in the country where they will be followed will be excluded, to reassure the same follow up within the study population.
- •Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.
- •Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.
- •Claustrophobia, making MR follow up impossible without sedation.
- •Alcohol- or narcotic abuses that effect compliance to the follow up.
- •Uncontrolled neoplastic disease.
结局指标
主要结局
The numbers of participants with preserve hearing
时间窗: up to five years after enrollment
Baseline audiometric investigation will be performed at time of enrollment. Patients will be followed with audiometric investigations after 1, 3 and 5 years after gamma knife or conservative treatment.Primary endpoint will be numbers of patients with preserve hearing for each treatment arm.
次要结局
- Tumor control(1, 2, 5 years after enrollment)
研究者
Petter Forander
MD, PhD
Karolinska Institutet