Stereotactic Radiation in Vestibular Schwannoma
Primary Purpose
Vestibular Schwannoma
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
stereotactic radiotherapy
stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Schwannoma focused on measuring Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
stereotactic radiosurgery
stereotactic radiotherapy
Arm Description
Radio surgery single fraction 12 Gy
Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
Outcomes
Primary Outcome Measures
audiogram
change from baseline audiogram at 6 months,1 year and 2 year
Secondary Outcome Measures
number of participant with adverse event
the new number of adverse event after radiation at 6 month,1 and 2 year
tumor size
change in tumor size at 6 month, 1 year and 2 year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01449604
Brief Title
Stereotactic Radiation in Vestibular Schwannoma
Official Title
Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stereotactic radiosurgery
Arm Type
Active Comparator
Arm Description
Radio surgery single fraction 12 Gy
Arm Title
stereotactic radiotherapy
Arm Type
Active Comparator
Arm Description
Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiotherapy
Intervention Description
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Other Intervention Name(s)
SRS
Intervention Description
Radio surgery 12 Gy
Primary Outcome Measure Information:
Title
audiogram
Description
change from baseline audiogram at 6 months,1 year and 2 year
Time Frame
two year
Secondary Outcome Measure Information:
Title
number of participant with adverse event
Description
the new number of adverse event after radiation at 6 month,1 and 2 year
Time Frame
2 year
Title
tumor size
Description
change in tumor size at 6 month, 1 year and 2 year
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Putipun Puataweepong, M.D.
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Radiation in Vestibular Schwannoma
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