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Stereotactic Radiation in Vestibular Schwannoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Putipun Puataweepong, Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01449604
First received: October 2, 2011
Last updated: October 6, 2011
Last verified: October 2011
History of Changes

October 2, 2011
October 6, 2011
October 2011
October 2013   (final data collection date for primary outcome measure)
audiogram [ Time Frame: two year ] [ Designated as safety issue: Yes ]
change from baseline audiogram at 6 months,1 year and 2 year
Same as current
Complete list of historical versions of study NCT01449604 on ClinicalTrials.gov Archive Site
  • number of participant with adverse event [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    the new number of adverse event after radiation at 6 month,1 and 2 year
  • tumor size [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    change in tumor size at 6 month, 1 year and 2 year
Same as current
 
 
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Vestibular Schwannoma
  • Radiation: stereotactic radiotherapy
    Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
    Other Name: stereotactic radiotherapy
  • 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
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT01449604
RAMART0111
No
Putipun Puataweepong, Ramathibodi Hospital
Ramathibodi Hospital
 
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