Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

Stanford University157 enrolled

Overview

The investigators study is to investigate safety and efficacy of performing a planned incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet avoid tumor recurrence by post-operative radiation therapy.

The current standard treatment of a large tumor of the balance nerve (acoustic neuroma or vestibular schwannoma) is surgical resection. Complete removal of such tumor is associated with significant risks of hearing loss and facial paralysis whereas incomplete removal of the tumor is associated with significant risks of regrowth. Stereotactic radiation is a well accepted therapy aiming at stopping the growth of smaller acoustic neuromas before their sizes become large enough to cause problems. The purpose of our study is to determine whether the combination of subtotal resection followed by stereotactic radiation of the remnant can control large acoustic neuromas without the significant risks associated with complete resection.

Study Type

OBSERVATIONAL

Enrollment

157

Conditions

Neuroma, Acoustic

Interventions

MicrosurgeryPROCEDURE

Patient would under to total, near-total, or subtotal resection of tumor

Stereotactic radiation therapyPROCEDURE

Patient who has sign of growth of tumor remnant would undergo this treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with acoustic neuromas the widest diameter of 2.5 cm or larger at the cerebellopontine angle are eligible for this trial. * Patients that are deemed good surgical candidates based on age, general health, genetic predispositions, and hearing in contralateral side would be included as the subjects of this trial. * Although we would include patients with neurofibromatosis II in this trial, considering their genetic predisposition for recurrence, we would analyze their outcome as a separate group. Exclusion Criteria: * Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.

Locations (9)

Stanford University School of Medicine

Stanford, California, United States

George Washington University

Washington D.C., District of Columbia, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Outcomes

Primary Outcomes

Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's

Time frame: 10 years

Secondary Outcomes

Facial nerve function measured on House-Brackmann scale

Time frame: 10 y

Data from ClinicalTrials.gov

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