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An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Radiosurgical thalamotomy
CyberKnife
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring tremor, Parkinson disease, functional radioablation, Cyber Knife radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice BranchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiosurgical thalamotomy

Arm Description

Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy

Outcomes

Primary Outcome Measures

Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)

Secondary Outcome Measures

Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)
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)
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

Full Information

First Posted
February 22, 2015
Last Updated
April 1, 2015
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT02406105
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
tremor, Parkinson disease, functional radioablation, Cyber Knife radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiosurgical thalamotomy
Arm Type
Experimental
Arm Description
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Intervention Type
Radiation
Intervention Name(s)
Radiosurgical thalamotomy
Intervention Description
Cybernetic microradiosurgery based thalamotomy
Intervention Type
Drug
Intervention Name(s)
CyberKnife
Primary Outcome Measure Information:
Title
Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale
Description
Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)
Description
Safety of treatment will be evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema
Time Frame
1 year
Title
Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)
Description
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.
Time Frame
2 years
Title
Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leszek Miszczyk, MD, PhD
Phone
0048322788001
Email
leszek@io.gliwice.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leszek Miszczyk, MD, PhD
Organizational Affiliation
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Official's Role
Study Director
Facility Information:
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
City
Gliwice
State/Province
Wybrzeze AK 15
ZIP/Postal Code
44-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leszek Miszczyk, MD. PhD
Phone
+48322788001
Email
leszek@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Leszek Miszczyk, MD, PhD
First Name & Middle Initial & Last Name & Degree
Grzegorz Wozniak, MD PhD
First Name & Middle Initial & Last Name & Degree
Agata Roch-Zniszczol, MD
First Name & Middle Initial & Last Name & Degree
Dawid Larysz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lukasz Zarudzki, MD
First Name & Middle Initial & Last Name & Degree
Malgorzata Fudzinska
First Name & Middle Initial & Last Name & Degree
Agnieszka Rozek

12. IPD Sharing Statement

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An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

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