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Active, not recruitingNCT01199978Updated Sep 11, 2026

Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

A Phase 2 interventional study of Fractionated proton radiation and Losartan in Vestibular Schwannoma and Acoustic Neuroma, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Vestibular Schwannoma
  • Acoustic Neuroma

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Keywords

  • radiation
  • fractionated proton radiation
03

In context

Neuroma, Acoustic

98 studies on the registry are indexed under Neuroma, Acoustic; 27 are open to participants now.

This study's enrollment of 30 is above the median of 27 across 66 interventional studies indexed under Neuroma, Acoustic.

Browse Neuroma, Acoustic studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Fractionated Proton Radiation

    Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects

    Radiation: Fractionated proton radiation · Drug: Losartan

Interventions

  • RadiationFractionated proton radiation

    Given daily for approximately 5.5 weeks

  • DrugLosartan

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

    Also known as: Cozaar

06

What researchers measure

Primary outcomes

  1. Characterization of long-term hearing effects

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

    Time frame: 5 years

Secondary outcomes

  1. Local control rate after fractionated proton radiation

    Time frame: 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.

    Time frame: 5 years

  3. Incidence of second tumors after fractionated proton radiation

    Time frame: 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.

    Time frame: 5 years

  5. Impact of Losartan on hearing preservation

    Time frame: 5 years

  6. Impact of Losartan on circulating biomarkers

    Time frame: 5 years

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01199978
Lead sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
Helen A. Shih, MD (Attending Radiation Oncologist, Massachusetts General Hospital) — Principal investigator
First posted
Sep 13, 2010
Start date
Mar 8, 2011
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 11, 2026

Study contacts

Helen A. Shih, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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