Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

NCT ID: NCT01199978

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-08
• Study Completion Date: 2026-11-30

Brief 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.

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.

Conditions

Vestibular Schwannoma; Acoustic Neuroma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractionated Proton Radiation

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

Group Type: OTHER

Fractionated proton radiation

Intervention Type: RADIATION

Given daily for approximately 5.5 weeks

Losartan

Intervention Type: DRUG

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

Interventions

Fractionated proton radiation

Given daily for approximately 5.5 weeks

Intervention Type: RADIATION

Losartan

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

Intervention Type: DRUG

Other Intervention Names

Cozaar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helen A. Shih, MD

Attending Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen A. Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35229827 (View on PubMed)

Other Identifiers

10-218

Identifier Type: -

Identifier Source: org_study_id