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Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy
This study is currently recruiting participants.
Verified April 2017 by Ashkan Monfared, George Washington University
Sponsor:
Stanford University
Collaborators:
University of Cincinnati
Baylor College of Medicine
Weill Medical College of Cornell University
University of Iowa
University of Texas
George Washington University
Indiana University
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Ashkan Monfared, George Washington University
ClinicalTrials.gov Identifier:
NCT01129687
First received: March 10, 2010
Last updated: April 24, 2017
Last verified: April 2017
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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:
MedlinePlus related topics:
Acoustic Neuroma
Genetic and Rare Diseases Information Center resources:
Acoustic Neuroma
Neurofibroma
Schwannoma
Carcinoid Tumor
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Ashkan Monfared, George Washington University:
Primary Outcome Measures:
- Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's [ Time Frame: 10 years ]
Secondary Outcome Measures:
- Facial nerve function measured on House-Brackmann scale [ Time Frame: 10 y ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2025 |
| Estimated Primary Completion Date: | March 2025 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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, D.C., 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, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Terese Stevens 317-278-1255 tstevens@iupui.edu | |
| Principal Investigator: Rick Nelson, 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, Louisiana | |
| Louisiana State University | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: Therese Demouy, MD 225-765-6833 Therese.Demouy@ololrmc.com | |
| Contact: Moises Arriaga, MD (504) 568-3779 maa@neurotologic.com | |
| 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 | Active, not recruiting |
| Cincinnati, Ohio, United States | |
| 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
Indiana University
Louisiana State University Health Sciences Center in New Orleans
Investigators
| Study Director: | Ashkan Monfared, MD | George Washington University |
| Study Director: | Robert K Jackler, MD | Stanford University |
More Information
| Responsible Party: | Ashkan Monfared, Principal Investigator, George Washington University |
| ClinicalTrials.gov Identifier: | NCT01129687 History of Changes |
| Other Study ID Numbers: |
SU-03052010-5142 |
| Study First Received: | March 10, 2010 |
| Last Updated: | April 24, 2017 |
Additional relevant MeSH terms:
|
Neuroma Neuroma, Acoustic Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neurilemmoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Cranial Nerve Neoplasms |
Nervous System Neoplasms Neoplasms by Site Peripheral Nervous System Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 22, 2017