Stereotactic Radiation in Vestibular Schwannoma

Phase 3

• Conditions: Vestibular Schwannoma
• Interventions: Radiation: stereotactic radiosurgery; Radiation: stereotactic radiotherapy

• Registration Number: NCT01449604
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-02
• Study First Submitted QC: 2011-10-06
• Last Update Submitted: 2011-10-06
• Study First Posted: 2011-10-10
• Last Update Posted: 2011-10-10
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stereotactic radiosurgery	stereotactic radiosurgery	Radio surgery single fraction 12 Gy
stereotactic radiotherapy	stereotactic radiotherapy	Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction

Primary Outcome Measures

Name	Time	Method
audiogram	two year	change from baseline audiogram at 6 months,1 year and 2 year

Secondary Outcome Measures

Name	Time	Method
number of participant with adverse event	2 year	the new number of adverse event after radiation at 6 month,1 and 2 year
tumor size	2 year	change in tumor size at 6 month, 1 year and 2 year