New proton beam therapy aims to save hearing in brain tumor patients
NCT ID NCT01199978
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study tests a precise type of radiation called proton therapy for people with a non-cancerous brain tumor called vestibular schwannoma. The goal is to see if this treatment can preserve hearing and control tumor growth while reducing side effects. About 30 adults with useful hearing in the affected ear will receive fractionated proton radiation and be followed long-term.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Mar 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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