An Effectiveness & Toxicity of CyberKnife Based Radiosurgery for Parkinson

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Parkinson Disease

Clinical Trial Details

NCT number	NCT02406105
Study type	Interventional
Source	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Contact	Leszek Miszczyk, MD, PhD
Phone	0048322788001
Email	leszek@io.gliwice.pl
Status	Recruiting
Phase	Phase 2
Start date	January 2015
Completion date	December 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms