Stereotactic Radiation in Vestibular Schwannoma

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Vestibular Schwannoma

Treatments: Radiation: stereotactic radiotherapy; Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01449604

RAMART0111

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

stereotactic radiosurgery

Active Comparator group

Description:

Radio surgery single fraction 12 Gy

Treatment:

Radiation: stereotactic radiosurgery

stereotactic radiotherapy

Active Comparator group

Description:

Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction

Treatment:

Radiation: stereotactic radiotherapy