Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Neuroma, Acoustic
• Intervention / Treatment: 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
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Louisiana State University
  • New York
    • New York, New York, United States
      • Weill Cornell Medical College
  • Ohio
    • Cincinnati, Ohio, United States
      • University of Cincinnati
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with large acoustic neuromas measuring 2.5cm in longest dimension in the cerebellopontine angle.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Facial nerve function measured on House-Brackmann scale	10 y

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Baylor College of Medicine; University of Iowa; Weill Medical College of Cornell University; George Washington University; University of Texas; Indiana University; Louisiana State University Health Sciences Center in New Orleans; University of Cincinnati
• Investigators: Study Director: Ashkan Monfared, MD, George Washington University; Study Director: Robert K Jackler, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (ACTUAL): May 8, 2022
• Study Completion (ACTUAL): May 8, 2022

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: May 24, 2010
• First Posted (ESTIMATE): May 25, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neurilemmoma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuroma; Neuroma, Acoustic
• Other Study ID Numbers: SU-03052010-5142