Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

NCT01129687 | Completed

• 1 other identifier: SU-03052010-5142
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 9

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.

Conditions

Neuroma, Acoustic

Outcome Measures

Primary Outcomes (1)

• Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's

  10 years

Secondary Outcomes (1)

• Facial nerve function measured on House-Brackmann scale

  10 y

Study Arms (1)

ANSRS group

Patients qualifying for the study.

Procedure: Microsurgery; Procedure: Stereotactic radiation therapy

Interventions

Microsurgery PROCEDURE

Patient would under to total, near-total, or subtotal resection of tumor

ANSRS group

Stereotactic radiation therapy PROCEDURE

Patient who has sign of growth of tumor remnant would undergo this treatment

ANSRS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.

Sponsors & Collaborators

• Stanford University: lead
• University of Cincinnati: collaborator
• Baylor College of Medicine: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Iowa: collaborator
• University of Texas: collaborator
• George Washington University: collaborator
• Indiana University: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (9)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Louisiana State University

Baton Rouge, Louisiana, 70808, United States

Location

Weill Cornell Medical College

New York, New York, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Microsurgery; Radiosurgery

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; 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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Micromanipulation; Investigative Techniques; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures

Study Officials

• Ashkan Monfared, MD

  George Washington University

  STUDY DIRECTOR

• Robert K Jackler, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: May 25, 2010
• Study Start: March 1, 2005
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (9)