Multisession Radiosurgery in Large Meningiomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Local control evaluation assessed on MRI-based volumetric lesion measurements.
研究概览
简要总结
This is a prospective observational trial consisting of robotic multisession radiosurgery (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.
详细描述
To date, the treatment of choice for intracranial meningiomas is surgical removal.
Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. Despite being a well-established treatment for intracranial meningiomas, SRS might be associated with significant morbidity when large volumes or critical sites are treated. Hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity.
The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment).
The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0 and BPN BSN House-Brackman and sensorineural internation scale assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •either histologically confirmed or imaging-defined benign meningioma diagnosis;
- •large or medium lesion size and/or in critical area (e.i. perichiasmatic area);
- •signed specific informed consent;
- •age ≥ 18 years;
- •for female patients, execution of pregnancy blood test;
- •Karnofsky Performance Status (KPS) ≥ 70.
排除标准
- •histologically confirmed diagnosis of atypical or malignant meningiomas;
- •patients who had received prior radiotherapy in the same site;
- •pregnancy;
- •allergy for contrast medium;
- •neurofibromatosis diagnosis.
结局指标
主要结局
Local control evaluation assessed on MRI-based volumetric lesion measurements.
时间窗: change from baseline volume lesion at 5 years
Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images
Radiation-related toxicities.
时间窗: change from baseline neurological assessment at 5 years.
evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0
次要结局
- Neurological assessment of facial nerve dysfunction(every 6 months, up to 3 years. Afterwards, every year up to 5 years.)
- Neurological assessment of acoustic nerve dysfunction(every 6 months, up to 3 years. Afterwards, every year up to 5 years.)
- Neurological assessment of trigeminal pain(every 6 months, up to 3 years. Afterwards, every year up to 5 years.)
- Neurological assessment of trigeminal dysfunction(every 6 months, up to 3 years. Afterwards, every year up to 5 years.)
- Neurological assessment of visual dysfunction(every 6 months, up to 3 years. Afterwards, every year up to 5 years.)