An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease
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|ClinicalTrials.gov Identifier: NCT02406105|
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Radiation: Radiosurgical thalamotomy Drug: CyberKnife||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Radiation: Radiosurgical thalamotomy
Cybernetic microradiosurgery based thalamotomy
- 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)
- Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406105
|Contact: Leszek Miszczyk, MD, PhDemail@example.com|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch||Recruiting|
|Gliwice, Wybrzeze AK 15, Poland, 44-100|
|Contact: Leszek Miszczyk, MD. PhD +48322788001 firstname.lastname@example.org|
|Principal Investigator: Leszek Miszczyk, MD, PhD|
|Sub-Investigator: Grzegorz Wozniak, MD PhD|
|Sub-Investigator: Agata Roch-Zniszczol, MD|
|Sub-Investigator: Dawid Larysz, MD, PhD|
|Sub-Investigator: Lukasz Zarudzki, MD|
|Sub-Investigator: Malgorzata Fudzinska|
|Sub-Investigator: Agnieszka Rozek|
|Study Director:||Leszek Miszczyk, MD, PhD||Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland|