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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
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Schwannoma focused on measuring Stereotactic radiotherapy, SRS, SRT, vestibular schwannoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2011
    Last Updated
    October 6, 2011
    Sponsor
    Ramathibodi Hospital
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    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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