Observational Study on Multisession Radiosurgery for Optic Nerve Sheath Meningiomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- visual function outcome
研究概览
简要总结
Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation, surgery and radiotherapy, but to date none of these has become the clear treatment of choice.
The role of the radiotherapy remained uncertain because of the concern about radiation related optic neuropathy In the recent past two large series of patients treated with a fractionated stereotactic radiotherapy confirmed these positive experiences in tumour control and greatly reduced the concern about the treatment related toxicity.
Under the light of successful meningiomas treatment, radiosurgery, had proposed as a treatment option. Single session, high conformality, frame based radiosurgery systems are seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic nerve.
The first experience in ONSMs treatment with multisession radiosurgery treatment was quite promising.
The aim of the present study is to prospectively evaluate the efficacy and safety of multisession radiosurgery in ONSMs treatment.
In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present study.
All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated both for tumor growth control and visual function.
详细描述
Introduction Optic Nerve Sheath Meningiomas (ONSMs) are rare tumours. They represent approximately the 2% of all orbital tumours, 1-2% of intracranial meningiomas and one third of the optic nerve lesions (23, 32, 42, 43). Usually these tumour are monolateral but 5% have a bilateral development (33) On the base of the growth pattern these tumours can be classified in primary and secondary forms. The former type arise from the arachnoid cap cell of the fibrous dural capsule of the optic nerve and they usually growth circumferentially along the nerve. Primary ONSMs can be further subdivided in orbital and intracanalicular forms.
Secondary ONSMs usually arise from the sphenoid ridge or the tuberculum sellae and subsequently spread into the optic canal and the orbit (14, 42).
Often the pathological studies show meningotheliomatous or transitional histology.
Middle aged woman are the most often affected (4, 36, 44). The most frequent presentation symptom is a visual loss, both in acuity or visual field. This is nearly an expression of an optic nerve direct compression and of the vascular rearrangement.
Optic nerve atrophy is common. Optociliary shunts are a late and rare sign but they are the direct expression of compressive optic neuropathy and it can be pathognomonic for the diagnosis of ONSM (35, 43).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 years old
- •Patients with suspected optic nerve sheath meningioma (single lesion) Pain and/or neurologic deficit
- •Written consent
排除标准
- •Pregnancy
- •Bilateral meningioma or chiasma involved
- •Allergy to contrast medium
研究组 & 干预措施
ONSM Multisession Radiosurgery
Multisession Radiosurgery
干预措施: Multisession Radiosurgery (Radiation)
结局指标
主要结局
visual function outcome
时间窗: 5 year
pre and post treatment visual acuity and visual field will be evaluated
次要结局
- PFS - progression free survival(5 year)
- Safety: level of toxicity(5 year)