Neuroma, AcousticNCT01129687
Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy
An observational study of Neuroma, Acoustic, run by Stanford University at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma, Acoustic
- What is being tested?
- Microsurgery and Stereotactic radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 157 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2005to 8 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with large acoustic neuromas measuring 2.5cm in longest dimension in the cerebellopontine angle.
Who may be able to join
- 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.
Who cannot join
- Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Louisiana State University
Baton Rouge, Louisiana, 70808
University of Cincinnati
Cincinnati, Ohio
University of Texas Southwestern
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Weill Cornell Medical College
New York, New York
Stanford University School of Medicine
Stanford, California, 94305
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas
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.
Read the 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.
- Conditions
- Neuroma, Acoustic
- Being tested
- Microsurgery, Stereotactic radiation therapy
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrosurgeryProcedure or surgery
Patient would under to total, near-total, or subtotal resection of tumor
Stereotactic radiation therapyProcedure or surgery
Patient who has sign of growth of tumor remnant would undergo this treatment
| Study group | Role | What they receive |
|---|---|---|
| ANSRS group | Patients qualifying for the study. Receives: Procedure: Microsurgery; Procedure: Stereotactic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's
Measured: 10 years
Secondary outcomes (1)
Facial nerve function measured on House-Brackmann scale
Measured: 10 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMar 2005
- Primary completion8 May 2022
- Study completion8 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuroma, AcousticStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Ashkan Monfared, George Washington University
- Investigators
- Ashkan Monfared, MD, Study director, George Washington UniversityRobert K Jackler, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129687
- Sponsor's protocol ID
- SU-03052010-5142
- Status last verified
- May 2022
- First submitted
- 10 Mar 2010
- Last updated
- 10 May 2022
- Results posted
- No
Publications
Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study, Part I-Facial Nerve Outcomes and Degree of Resection. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004199. Online ahead of print.
PubMed 42714161Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study-Part III Perioperative Measures and Complications. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004201. Online ahead of print.
PubMed 42714146Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study-Part II- Tumor Regrowth. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004200. Online ahead of print.
PubMed 42714141
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Analysis of Treatment Outcome in Patients With Large Acoustic Neuromas
- ClinicalTrials.gov ID
- NCT01129687
- Acronym / sponsor ID
- SU-03052010-5142
- Conditions
- Neuroma, Acoustic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- 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
- Study start
- Mar 2005
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 8 May 2022 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANSRS group | – | Procedure: Microsurgery, Procedure: Stereotactic radiation therapyPatients qualifying for the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with large acoustic neuromas measuring 2.5cm in longest dimension in the cerebellopontine angle.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrosurgeryPatient would under to total, near-total, or subtotal resection of tumor | Procedure or surgery | ANSRS group |
| Stereotactic radiation therapyPatient who has sign of growth of tumor remnant would undergo this treatment | Procedure or surgery | ANSRS group |
Primary outcome
Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's
Time frame: 10 years
1 secondary outcome
Facial nerve function measured on House-Brackmann scale
Time frame: 10 y
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 42714161Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study, Part I-Facial Nerve Outcomes and Degree of Resection. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004199. Online ahead of print.
- Derived from this study: PubMed 42714146Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study-Part III Perioperative Measures and Complications. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004201. Online ahead of print.
- Derived from this study: PubMed 42714141Monfared A, Gurgel RK, Theodosopoulos PV, Haupt TL, Warnick RE, Sabetrasekh P, Corrales CE, Vaisbuch Y, Blevins NH, Oghalai JS, Sweeney AD, Hansen MR, Gantz BJ, Nelson RF, Kutz JW, Isaacson B, Arriaga MA, Maghami S, Amdur RL, Zhang H, Selesnick SH, Jackler RK. Long-Term Outcomes of Subtotal Resection for Large Vestibular Schwannomas: Results From the Acoustic Neuroma Subtotal Resection Study-Part II- Tumor Regrowth. Neurosurgery. 2026 Sep 9. doi: 10.1227/neu.0000000000004200. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashkan Monfared, MD study director
George Washington University
Robert K Jackler, MD study director
Stanford University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroma, Acoustic, run by Stanford University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for stereotactic radiation therapy should tumor remnant grow on annual MRI's (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.