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Stereotactic Radiation in Vestibular Schwannoma

NCT ID: NCT01449604

Last Updated: 2011-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Vestibular Schwannoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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stereotactic radiosurgery

Radio surgery single fraction 12 Gy

Group Type ACTIVE_COMPARATOR

stereotactic radiosurgery

Intervention Type RADIATION

Radio surgery 12 Gy

stereotactic radiotherapy

Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction

Group Type ACTIVE_COMPARATOR

stereotactic radiotherapy

Intervention Type RADIATION

Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

Interventions

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stereotactic radiotherapy

Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

Intervention Type RADIATION

stereotactic radiosurgery

Radio surgery 12 Gy

Intervention Type RADIATION

Other Intervention Names

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SRS

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Putipun Puataweepong

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Putipun Puataweepong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Other Identifiers

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RAMART0111

Identifier Type: -

Identifier Source: org_study_id