Stereotactic Radiation in Vestibular Schwannoma

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01449604

Enrollment

200

Registered

2011-10-10

Start date

2011-10-31

Completion date

2013-10-31

Last updated

2011-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Schwannoma

Keywords

Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma

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.

Interventions

RADIATIONstereotactic radiotherapy

Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

RADIATIONstereotactic radiosurgery

Radio surgery 12 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
audiogram	two year	change from baseline audiogram at 6 months,1 year and 2 year

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026