Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01129687
Recruitment Status : Recruiting
First Posted : May 25, 2010
Last Update Posted : April 26, 2017
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

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 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

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

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 ]

Information from the National Library of Medicine

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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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129687

Contact: ashkan monfared, MD (202)741-3250

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: ashkan monfared, MD    202-741-3250   
Principal Investigator: Dr Robert Jackler         
Study Director: Ashkan Monfared         
United States, District of Columbia
George Washington University Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Ashkan Monfared, MD    202-741-3017   
Contact: Shelly Greene    202-741-3450   
Principal Investigator: Ashkan Monfared, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Terese Stevens    317-278-1255   
Principal Investigator: Rick Nelson, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Marlan Hansen, MD    319-353-7151   
Principal Investigator: Marlan Hansen, MD         
United States, Louisiana
Louisiana State University Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Therese Demouy, MD    225-765-6833   
Contact: Moises Arriaga, MD    (504) 568-3779   
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States
Contact: Teresa Valderrama, MPH    646-962-5399   
Principal Investigator: Samuel Selesnick         
United States, Ohio
University of Cincinnati Active, not recruiting
Cincinnati, Ohio, United States
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Anna Bryan    214-648-2913   
Contact: Walter Kutz, MD    214-648-2432   
Principal Investigator: Walter Kutz, MD         
Baylor College of Medicine Active, not recruiting
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
Study Director: Ashkan Monfared, MD George Washington University
Study Director: Robert K Jackler, MD Stanford University

Responsible Party: Ashkan Monfared, Principal Investigator, George Washington University Identifier: NCT01129687     History of Changes
Other Study ID Numbers: SU-03052010-5142
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Neuroma, Acoustic
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
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