Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Stanford University
Sponsor:
Collaborators:
University of Cincinnati
Baylor College of Medicine
Weill Medical College of Cornell University
University of Iowa
University of Texas
George Washington University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01129687
First received: March 10, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Neuroma, Acoustic
Procedure: Microsurgery
Procedure: Stereotactic radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Facial nerve function measured on House-Brackmann scale [ Time Frame: 10 y ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2005
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129687

Contacts
Contact: ashkan monfared, MD (202)741-3250 monfared@gmail.com

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: ashkan monfared, MD    202-741-3250    monfared@gmail.com   
Principal Investigator: Dr Robert Jackler         
Study Director: Ashkan Monfared         
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Ashkan Monfared, MD    202-741-3017    monfared@gmail.com   
Contact: Shelly Greene    202-741-3450    sgreene@mfa.gwu.edu   
Principal Investigator: Ashkan Monfared, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Marlan Hansen, MD    319-353-7151    marlan-hansen@uiowa.edu   
Principal Investigator: Marlan Hansen, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States
Contact: Teresa Valderrama, MPH    646-962-5399    tev2002@med.cornell.edu   
Principal Investigator: Samuel Selesnick         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States
Contact: Carolyn Koenig, RN    513-558-3518    koenigch@UCMAIL.UC.EDU   
Principal Investigator: Phillip Theodosopoulos         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Anna Bryan    214-648-2913    Anna.Bryan@utsouthwestern.edu   
Contact: Walter Kutz, MD    214-648-2432    Walter.Kutz@utsouthwestern.edu   
Principal Investigator: Walter Kutz, MD         
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States
Sponsors and Collaborators
Stanford University
University of Cincinnati
Baylor College of Medicine
Weill Medical College of Cornell University
University of Iowa
University of Texas
George Washington University
Investigators
Study Director: Ashkan Monfared Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01129687     History of Changes
Other Study ID Numbers: SU-03052010-5142
Study First Received: March 10, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroma, Acoustic
Neuroma
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Ear Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neurilemmoma
Neuroectodermal Tumors
Neuroendocrine Tumors
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Peripheral Nervous System Neoplasms
Retrocochlear Diseases
Vestibulocochlear Nerve Diseases

ClinicalTrials.gov processed this record on October 23, 2014