Stereotactic Radiation in Vestibular Schwannoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Ramathibodi Hospital.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Putipun Puataweepong, Ramathibodi Hospital Identifier:
First received: October 2, 2011
Last updated: October 6, 2011
Last verified: October 2011
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 Intervention Phase
Vestibular Schwannoma
Radiation: stereotactic radiotherapy
Radiation: stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma

Resource links provided by NLM:

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • audiogram [ Time Frame: two year ] [ Designated as safety issue: Yes ]
    change from baseline audiogram at 6 months,1 year and 2 year

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01449604

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

Responsible Party: Putipun Puataweepong, Assistant professor, Ramathibodi Hospital Identifier: NCT01449604     History of Changes
Other Study ID Numbers: RAMART0111 
Study First Received: October 2, 2011
Last Updated: October 6, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
Stereotactic radiotherapy
vestibular schwannoma

Additional relevant MeSH terms:
Neuroma, Acoustic
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Ear Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroendocrine Tumors
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Peripheral Nervous System Neoplasms
Retrocochlear Diseases
Vestibulocochlear Nerve Diseases processed this record on May 26, 2016