Clinical Trial: Stereotactic Radiation in Vestibular Schwannoma

Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of 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 Summary:

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.


Sponsor: Ramathibodi Hospital

Current Primary Outcome: audiogram [ Time Frame: two year ]

change from baseline audiogram at 6 months,1 year and 2 year


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of participant with adverse event [ Time Frame: 2 year ]
    the new number of adverse event after radiation at 6 month,1 and 2 year
  • tumor size [ Time Frame: 2 year ]
    change in tumor size at 6 month, 1 year and 2 year


Original Secondary Outcome: Same as current

Information By: Ramathibodi Hospital

Dates:
Date Received: October 2, 2011
Date Started: October 2011
Date Completion: October 2013
Last Updated: October 6, 2011
Last Verified: October 2011