An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

Phase 2

• Conditions: Parkinson Disease
• Interventions: Radiation: Radiosurgical thalamotomy; Drug: CyberKnife

• Registration Number: NCT02406105
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-22
• Status Verified: 2015-03
• Study First Submitted QC: 2015-04-01
• Last Update Submitted: 2015-04-01
• Study First Posted: 2015-04-02
• Last Update Posted: 2015-04-02
• Primary Completion: 2018-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiosurgical thalamotomy	CyberKnife	Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Radiosurgical thalamotomy	Radiosurgical thalamotomy	Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy

Primary Outcome Measures

Name	Time	Method
Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale	1 year	Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)

Secondary Outcome Measures

Name	Time	Method
Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)	1 year	Safety of treatment will be evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema
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	None grading system of serial spectroscopy dedicated for such purpose exists. We will check spectra of metabolites in irradiated volume and proportions between them, trying to form conclusions considering necrosis/gliosis forming.
Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality	2 years

Trial Locations

Locations (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch; 🇵🇱 Gliwice, Wybrzeze AK 15, Poland