Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

Completed

• Conditions: Neuroma, Acoustic
• Interventions: Procedure: Microsurgery; Procedure: Stereotactic radiation therapy

• Registration Number: NCT01129687
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Status Verified: 2022-05
• Primary Completion: 2022-05-08
• Study Completion: 2022-05-08
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ANSRS group	Microsurgery	Patients qualifying for the study.
ANSRS group	Stereotactic radiation therapy	Patients qualifying for the study.

Primary Outcome Measures

Name	Time	Method
Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's	10 years

Secondary Outcome Measures

Name	Time	Method
Facial nerve function measured on House-Brackmann scale	10 y

Trial Locations

Locations (9)

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Louisiana State University; 🇺🇸 Baton Rouge, Louisiana, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States