Overview

This trial is active, not recruiting.

Condition vestibular schwannoma
Treatments stereotactic radiotherapy, stereotactic radiosurgery
Phase phase 3
Sponsor Ramathibodi Hospital
Start date October 2011
End date October 2013
Trial size 200 participants
Trial identifier NCT01449604, RAMART0111

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Radio surgery single fraction 12 Gy
stereotactic radiosurgery SRS
Radio surgery 12 Gy
(Active Comparator)
Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
stereotactic radiotherapy stereotactic radiotherapy
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

Primary Outcomes

Measure
audiogram
time frame: two year

Secondary Outcomes

Measure
number of participant with adverse event
time frame: 2 year
tumor size
time frame: 2 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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)

Additional Information

Official title Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
Principal investigator Putipun Puataweepong, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Ramathibodi Hospital.