Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy
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ClinicalTrials.gov Identifier: NCT01129687 |
Recruitment Status :
Completed
First Posted : May 25, 2010
Last Update Posted : May 10, 2022
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Condition or disease | Intervention/treatment |
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Neuroma, Acoustic | Procedure: Microsurgery Procedure: Stereotactic radiation therapy |
Study Type : | Observational |
Actual Enrollment : | 157 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 |
Actual Primary Completion Date : | May 8, 2022 |
Actual Study Completion Date : | May 8, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
ANSRS group
Patients qualifying for the study.
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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 |
- Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's [ Time Frame: 10 years ]
- Facial nerve function measured on House-Brackmann scale [ Time Frame: 10 y ]

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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 |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01129687
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 |
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 |
ClinicalTrials.gov Identifier: | NCT01129687 |
Other Study ID Numbers: |
SU-03052010-5142 |
First Posted: | May 25, 2010 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
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 |