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Stereotactic Radiation in Vestibular Schwannoma

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ClinicalTrials.gov Identifier: NCT01449604
Recruitment Status : Unknown
Verified October 2011 by Putipun Puataweepong, Ramathibodi Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2011
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Radiation: stereotactic radiotherapy Radiation: stereotactic radiosurgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013


Arms and Interventions

Arm Intervention/treatment
Active Comparator: stereotactic radiosurgery
Radio surgery single fraction 12 Gy
Radiation: stereotactic radiosurgery
Radio surgery 12 Gy
Other Name: 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


Outcome Measures

Primary Outcome Measures :
  1. audiogram [ Time Frame: two year ]
    change from baseline audiogram at 6 months,1 year and 2 year


Secondary Outcome Measures :
  1. 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. tumor size [ Time Frame: 2 year ]
    change in tumor size at 6 month, 1 year and 2 year


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449604


Sponsors and Collaborators
Ramathibodi Hospital
Investigators
Principal Investigator: Putipun Puataweepong, M.D. Ramathibodi Hospital
More Information

Responsible Party: Putipun Puataweepong, Assistant professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01449604     History of Changes
Other Study ID Numbers: RAMART0111
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by Putipun Puataweepong, Ramathibodi Hospital:
Stereotactic radiotherapy
SRS
SRT
vestibular schwannoma

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases