An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
Study Overview
Brief Summary
Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Intervention: Radiosurgical thalamotomy (Radiation)
Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Intervention: CyberKnife (Drug)
Outcomes
Primary Outcomes
Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
Time Frame: 1 year
Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)
Secondary Outcomes
- 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)