Stereotactic Radiation in Vestibular Schwannoma

October 6, 2011 updated by: Putipun Puataweepong, Ramathibodi Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stereotactic radiosurgery
Radio surgery single fraction 12 Gy
Radiation: stereotactic radiosurgery
Radio surgery 12 Gy
Other Names:
  • SRS
Active Comparator: stereotactic radiotherapy
Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
Radiation: stereotactic radiotherapy
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 year
tumor size
Time Frame: 2 year
change in tumor size at 6 month, 1 year and 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Putipun Puataweepong, M.D., Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

October 2, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMART0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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