Clinical trial NCT01129687: Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy
Official title: Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroma, Acoustic
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: Baylor College of Medicine
name: Weill Medical College of Cornell University
name: University of Iowa
name: University of Texas
name: George Washington University
name: Indiana University
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2010-05-25
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with large acoustic neuromas measuring 2.5cm in longest dimension in the cerebellopontine angle.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's
timeFrame: 10 years
Secondary outcomes:
measure: Facial nerve function measured on House-Brackmann scale
timeFrame: 10 y
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baton Rouge
country: United States
facility: Louisiana State University
state: Louisiana
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: George Washington University
name: Ashkan Monfared, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Robert K Jackler, MD
role: STUDY_DIRECTOR
References: