An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.
详细描述
Basic treatment patients with Parkinson's disease (PD - Parkinson's disease) or essential tremor (ET - essential tremor) is a pharmacotherapy. In the case of lack of its effectiveness, the gold standard procedure is deep brain stimulation (DBS). Despite the proven efficacy, still remains a group of patients not eligible for this treatment. in such cases, ablation within the deep structures of the brain (thalamotomy, subthalamotomy, pallidotomy) can be considered.
Thermoablation and radiosurgery (SRS - Stereotactic radiosurgery) are used: SRS is prefered for patients who are not candidates for invasive procedures.
27 patients will be enrolled in this study. All patients will be immobilized in thermoplastic masks and planned (RT) on the base of CT/MRI fusion.
The initial total dose in the target volume (thalamic nuclei complex - VoP and VoA ) will be 70 Gy given in one fraction. The dose will be escalated every 5 Gy and the treatment effect and possible side effects will be evaluated. Dose escalation will be finished at a dose at which the effect of treatment will be satisfactory, or if side effects are unacceptable. The highest dose tested dose will be 110 Gy. Three patients will be irradiated with particular doses and observed at least 3 moths; then study will be continued.
Patients will be controlled 3, 6, 9, 12, 18 months after treatment completion and, next every each 6 months. Neurologic and neuropsychologic status, local effect (MRI ) and eventual toxicity will be checked during follow-up (FU).
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
- •Idiopatic Parkinson Disease (PD)
- •Lack of effective pharmacotherapy
- •Lack of possibilities of qualifications to DBS (deep brain stimulation) procedure
- •Informed consent for participation in the study and for radiotherapy
排除标准
- •Age under 18
- •Pregnancy
- •Other than PD induced tremor
- •Dementia, psychosis.
- •Poor performance status
- •Atrophic cerebral changes, structural changes in basal nuclei
- •Lack of informed consent.
研究组 & 干预措施
Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
干预措施: Radiosurgical thalamotomy (Radiation)
Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
干预措施: CyberKnife (Drug)
结局指标
主要结局
Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
时间窗: 1 year
Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)
次要结局
- Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)(1 year)
- Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)(2 years)
- Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality(2 years)