Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

• ClinicalTrials.gov Identifier: NCT01129687
• Recruitment Status: Active, not recruiting
• First Posted: May 25, 2010
• Last Update Posted: October 22, 2020
• Sponsor: Stanford University
• Collaborators: University of Cincinnati; Baylor College of Medicine; Weill Medical College of Cornell University; University of Iowa; University of Texas; George Washington University; Indiana University; Louisiana State University Health Sciences Center in New Orleans
• Information provided by (Responsible Party): Ashkan Monfared, George Washington University

Study Description

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.

Condition or disease	Intervention/treatment
Neuroma, Acoustic	Procedure: Microsurgery; Procedure: Stereotactic 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas
• Study Start Date: March 2005
• Estimated Primary Completion Date: March 2025
• Estimated Study Completion Date: March 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
ANSRS group; Patients qualifying for the study.	Procedure: Microsurgery; Patient would under to total, near-total, or subtotal resection of tumor; Procedure: Stereotactic radiation therapy; Patient who has sign of growth of tumor remnant would undergo this treatment

Outcome Measures

Primary Outcome Measures :

1. Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's [ Time Frame: 10 years ]

Secondary Outcome Measures :

1. Facial nerve function measured on House-Brackmann scale [ Time Frame: 10 y ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with large acoustic neuromas measuring 2.5cm in longest dimension in the cerebellopontine angle.

Criteria

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

United States, District of Columbia

George Washington University

Washington, District of Columbia, United States, 20037

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Louisiana

Louisiana State University

Baton Rouge, Louisiana, United States, 70808

United States, New York

Weill Cornell Medical College

New York, New York, United States

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75390

Baylor College of Medicine

Houston, Texas, United States

Sponsors and Collaborators

Stanford University

University of Cincinnati

Baylor College of Medicine

Weill Medical College of Cornell University

University of Iowa

University of Texas

George Washington University

Indiana University

Louisiana State University Health Sciences Center in New Orleans

Investigators

• Study Director: Ashkan Monfared, MD; George Washington University
• Study Director: Robert K Jackler, MD; Stanford University

More Information

• Responsible Party: Ashkan Monfared, Principal Investigator, George Washington University
• ClinicalTrials.gov Identifier: NCT01129687
• Other Study ID Numbers: SU-03052010-5142
• First Posted: May 25, 2010
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Additional relevant MeSH terms:

Neuroma; Neuroma, Acoustic; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases