Clinical trial NCT02406105: An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease
Official title: An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: tremor
Parkinson disease
functional radioablation
Cyber Knife radiosurgery
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
timeFrame: 1 year
Secondary outcomes:
measure: Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)
timeFrame: 1 year
measure: Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)
timeFrame: 2 years
measure: Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality
timeFrame: 2 years
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
state: Wybrzeze AK 15
Study officials:
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
name: Leszek Miszczyk, MD, PhD
role: STUDY_DIRECTOR
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