Stereotactic Radiation in Vestibular Schwannoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).

Detailed Description
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Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial. Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.

Official Title
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Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma

Conditions
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Vestibular Schwannoma

Intervention / Treatment
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* Radiation: stereotactic radiotherapy
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vestibular schwannoma tumor size not more than 3 cm. Exclusion Criteria: NF 2 patient underlying cerebrovascular disease tumor compress and efface brain stem ( Koos 4)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stereotactic radiosurgery<br>Radio surgery single fraction 12 Gy | Radiation: stereotactic radiosurgery<br>* Radio surgery 12 Gy<br>* Other names: SRS;|
| Active Comparator: stereotactic radiotherapy<br>Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction | Radiation: stereotactic radiotherapy<br>* Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| audiogram | change from baseline audiogram at 6 months,1 year and 2 year | two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participant with adverse event | the new number of adverse event after radiation at 6 month,1 and 2 year | 2 year | 
| tumor size | change in tumor size at 6 month, 1 year and 2 year | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SRS, Stereotactic radiotherapy, SRT, vestibular schwannoma