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Completed

NCT Number: NCT01129687

Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MICROSURGERY

Procedure

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

Stereotactic radiation therapy

Procedure

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

Primary outcomes

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

    Time frame: 10 years

Secondary outcomes

  1. Facial nerve function measured on House-Brackmann scale

    Time frame: 10 y

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Baylor College of Medicine
  • George Washington University
  • Indiana University
  • Louisiana State University Health Sciences Center in New Orleans
  • University of Cincinnati
  • University of Iowa
  • University of Texas
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2022
Study completion
2022
First posted
May 25, 2010
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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