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Stereotactic Radiation in Vestibular Schwannoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Putipun Puataweepong, Ramathibodi Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449604
First Posted: October 10, 2011
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Putipun Puataweepong, Ramathibodi Hospital
October 2, 2011
October 10, 2011
October 10, 2011
October 2011
October 2013   (Final data collection date for primary outcome measure)
audiogram [ Time Frame: two year ]
change from baseline audiogram at 6 months,1 year and 2 year
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Stereotactic Radiation in Vestibular Schwannoma
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).

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Vestibular Schwannoma
  • Radiation: stereotactic radiotherapy
    Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
  • Radiation: stereotactic radiosurgery
    Radio surgery 12 Gy
    Other Name: SRS
  • Active Comparator: stereotactic radiosurgery
    Radio surgery single fraction 12 Gy
    Intervention: Radiation: stereotactic radiosurgery
  • Active Comparator: stereotactic radiotherapy
    Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
    Intervention: Radiation: stereotactic radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
October 2013
October 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01449604
RAMART0111
No
Not Provided
Not Provided
Putipun Puataweepong, Ramathibodi Hospital
Ramathibodi Hospital
Not Provided
Principal Investigator: Putipun Puataweepong, M.D. Ramathibodi Hospital
Ramathibodi Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP