Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

NCT ID: NCT01129687

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2022-05-08

Brief Summary

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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

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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.

Conditions

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Neuroma, Acoustic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ANSRS group

Patients qualifying for the study.

Microsurgery

Intervention Type PROCEDURE

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

Stereotactic radiation therapy

Intervention Type PROCEDURE

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

Interventions

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Microsurgery

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

Intervention Type PROCEDURE

Stereotactic radiation therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Ashkan Monfared

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashkan Monfared, MD

Role: STUDY_DIRECTOR

George Washington University

Robert K Jackler, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

George Washington University

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

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Louisiana State University

Baton Rouge, Louisiana, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SU-03052010-5142

Identifier Type: -

Identifier Source: org_study_id

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