Stereotactic Radiation in Vestibular Schwannoma

Vestibular Schwannoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01449604
• Other study ID #: RAMART0111
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 2, 2011
• Last updated: October 6, 2011
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2011
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Radiation:
• stereotactic radiotherapy
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
• stereotactic radiosurgery
Radio surgery 12 Gy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	audiogram	change from baseline audiogram at 6 months,1 year and 2 year	two year	Yes
Secondary	number of participant with adverse event	the new number of adverse event after radiation at 6 month,1 and 2 year	2 year	Yes
Secondary	tumor size	change in tumor size at 6 month, 1 year and 2 year	2 year	No