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Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuroma, Acoustic

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Trial Information

Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Ashkan Monfared

Investigator Role:

Study Director

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SU-03052010-5142

NCT ID:

NCT01129687

Start Date:

March 2005

Completion Date:

March 2015

Related Keywords:

  • Neuroma, Acoustic
  • Neuroma
  • Neuroma, Acoustic

Name

Location

Baylor College of Medicine Houston, Texas  77030
University of Iowa Iowa City, Iowa  52242
Stanford University School of Medicine Stanford, California  94305-5317
George Washington University Washington, District of Columbia  20037
University of Cincinnati Cincinnati, Ohio  45267-0502
Weill Cornell Medical College New York, New York  10021
University of Texas Southwestern Dallas, Texas  75390