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Vestibular SchwannomaPhase 2NCT01199978

Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

A Phase 2 study testing Fractionated proton radiation and Losartan in people with Vestibular Schwannoma and Acoustic Neuroma, run by Massachusetts General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In this research study we are looking at another type of radiation called proton radiation which is known to spare surrounding normal tissues from radiation. The proton radiation will be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of the small tumor target. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vestibular Schwannoma, Acoustic Neuroma
What is being tested?
Fractionated proton radiation and Losartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
8 Mar 2011to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • MRI confirmed unilateral vestibular schwannoma within 8 weeks prior to study entry
  • Measurable disease, defined as a lesion that can be accurately measured in at least one dimension
  • No prior radiotherapy with dose delivered to structures in proximity to the internal acoustic canal is allowable
  • Participants must have baseline "useful hearing" defined at the discretion of the treating physician in the irradiated ear
  • 18 years of age or older
  • Life expectancy of greater than 60 months
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  • Karnofsky performance status 60 or greater
  • Diagnosis of neurofibromatosis 2 (NF2) is permitted
  • Women of child-bearing potential and men must agree to use adequate contraception during the interval of irradiation
  • Able to tolerate the supine position as required for the radiation treatment unit and able to tolerate rotation needed for treatment delivery
  • Able to tolerate the standard immobilization device that typically utilizes a dental impression mouth piece and thus requires breathing through the nasal passage.
  • Willing and able to comply with comprehensive audiologic testing, at baseline prior to radiation therapy, at 6 months from treatment completion, and at annual timepoints for 5 years after completion
  • Baseline Systolic Blood Pressure (BP) > 100mm Hg. This is based on the average of two values - separate seated, resting measurements taken five minutes apart. BP does not need to be checked in both arms unless a reading is below 110 mm Hg, in which case the other arm can be checked as well. If BP is checked in both arms, the higher value is deemed accurate for calculating the average.

Who cannot join

  • Participants who have had prior radiotherapy, with dose delivered to structures in proximity to the internal acoustic canal (IAC).
  • Participants with tumors (or residual tumor after surgery) measuring > 3cm in greatest dimension
  • Participants may not be receiving any other study agents
  • History of adverse reaction to radiotherapy
  • Participants may not already be on losartan, other angiotensin II type I receptor blocker (ARB), or on an angiotensin-converting enzyme (ACE) inhibitor prior to enrollment of this study.
  • Participants receiving any medications or substances that are known to cause ototoxicity are ineligible
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  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women
  • Individuals with a history of malignancy are ineligible except for the following circumstances. Individuals with a history of malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be a low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell squamous cell carcinoma of the skin.
  • HIV-positive individuals on combination antiretroviral therapy
  • Patients with co-existing major ear disease, such as chronic otitis, Menieres disease, or otosclerosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

In this research study we are looking at another type of radiation called proton radiation which is known to spare surrounding normal tissues from radiation. The proton radiation will be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of the small tumor target. Proton radiation delivers minimal radiation beyond the area of the tumor. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study, we are looking to determine the effects of fractionated proton radiotherapy on long-term hearing preservation and controlling tumor growth.

Read the detailed description
  • Proton radiation will be delivered daily for approximately 5.5 weeks. Participants will be assessed weekly for any side effects they may be experiencing.
  • Participants will have a follow-up visit 6 months after their last proton radiation treatment and then every year from the time of treatment completion for 5 years. The following tests and procedures will be performed at these visits: medical history, physical exam, MRI scan, comprehensive hearing tests and a questionnaire.
Being tested
Fractionated proton radiation, Losartan
Keywords
radiation, fractionated proton radiation
Medical subject headings
Neuroma, Acoustic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractionated proton radiationRadiation

    Given daily for approximately 5.5 weeks

  • LosartanDrug

    Also called Cozaar

    25mg or 50mg daily, oral administration, for approximately 6 months.

Study groups in NCT01199978
Study groupRoleWhat they receive
Fractionated Proton RadiationOtherSingle arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects
Receives: Radiation: Fractionated proton radiation; Drug: Losartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of long-term hearing effects

    Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas.

    Measured: 5 years

Secondary outcomes (6)

  1. Local control rate after fractionated proton radiation

    Measured: 5 years

  2. Delineation of dosimetric parameters after fractionated proton radiation

    The distribution of dosimetric parameters will be summarized, and their correlation to clinical outcomes, including hearing loss, will be explored.

    Measured: 5 years

  3. Incidence of second tumors after fractionated proton radiation

    Measured: 5 years

  4. Toxicity profile of Losartan given concurrently with proton radiation

    Toxicities associated with losartan before, during and after proton radiation will be summarized by grade according to CTCAE 4.0. The losartan cohort of 10 participants will provide 90% confidence interval of maximal width +/-27% based on the exact binomial distribution.

    Measured: 5 years

  5. Impact of Losartan on hearing preservation

    Measured: 5 years

  6. Impact of Losartan on circulating biomarkers

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study start8 Mar 2011
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199978
Sponsor's protocol ID
10-218
Status last verified
Sep 2025
First submitted
9 Sep 2010
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Saraf A, Pike LRG, Franck KH, Horick NK, Yeap BY, Fullerton BC, Wang IS, Abazeed ME, McKenna MJ, Mehan WA, Plotkin SR, Loeffler JS, Shih HA. Fractionated Proton Radiation Therapy and Hearing Preservation for Vestibular Schwannoma: Preliminary Analysis of a Prospective Phase 2 Clinical Trial. Neurosurgery. 2022 May 1;90(5):506-514. doi: 10.1227/neu.0000000000001869.

    PubMed 35229827

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fractionated proton radiation and Losartan in people with Vestibular Schwannoma and Acoustic Neuroma, run by Massachusetts General Hospital at 1 site 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 13 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Characterization of long-term hearing effects (time frame: 5 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 NCT01199978, which also lists 1 linked publication.

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 11 Sep 2026.

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