Stereotactic Radiation in Vestibular Schwannoma
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Purpose
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 |
- audiogram [ Time Frame: two year ] [ Designated as safety issue: Yes ]change from baseline audiogram at 6 months,1 year and 2 year
- 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
Other Name: stereotactic radiotherapy
|
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.
Eligibility| 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
More Information
No publications provided
| Responsible Party: | Putipun Puataweepong, Assistant professor, Ramathibodi Hospital |
| ClinicalTrials.gov 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 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 Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neuroma Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms by Site Cranial Nerve Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on June 17, 2013