Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

Neuroma, Acoustic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129687
• Other study ID #: SU-03052010-5142
• Status: Completed
• Start date: March 2005
• Est. completion date: May 8, 2022

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: May 8, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroma
• Neuroma, Acoustic

Intervention

Procedure:
• Microsurgery
Patient would under to total, near-total, or subtotal resection of tumor
• Stereotactic radiation therapy
Patient who has sign of growth of tumor remnant would undergo this treatment

Locations

Country	Name	City	State
United States	Louisiana State University	Baton Rouge	Louisiana
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Weill Cornell Medical College	New York	New York
United States	Stanford University School of Medicine	Stanford	California
United States	George Washington University	Washington	District of Columbia

Sponsors (9)

Lead Sponsor	Collaborator
Stanford University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's		10 years
Secondary	Facial nerve function measured on House-Brackmann scale		10 y