Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

Description

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.

Study Start Date

September 2010

Estimated Completion Date

September 2017

Interventions

  • Radiation: Fractionated proton radiation

Specialties

  • Internal Medicine: Hematology/Oncology,Radiology/Diagnostics
  • Neurology: Neurologic Oncology
  • Oncology: Neurologic Oncology,Pharmacology/Therapy
  • Radiology: Radiotherapy (XRT)

MeSH Terms

  • Neurilemmoma
  • Neuroma
  • Vestibular Schwannoma

Study ID

Massachusetts General Hospital -- 10-218

Status

Unknown

Trial ID

NCT01199978

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

30

Sponsor

Massachusetts General Hospital

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 as having hearing loss no greater than grade 2 in the irradiated ear
  • 18 years of age or older
  • Life expectancy of greater than 60 months
  • Karnofsky performance status 60 or greater
  • 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
  • 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

Exclusion Criteria

  • Participants who have had prior radiotherapy, with dose delivered to structures in proximity to the internal acoustic canal
  • Participants with tumors (or residual tumor after surgery) measuring > 3cm in greatest dimension
  • Participants with neurofibromatosis type 2 (NF2)
  • Participants may not be receiving any other study agents
  • History of adverse reaction to radiotherapy
  • 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None

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