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Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01199978
Recruitment Status : Recruiting
First Posted : September 13, 2010
Last Update Posted : December 11, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Acoustic Neuroma Radiation: Fractionated proton radiation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
Study Start Date : September 2010
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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
Given daily for approximately 5.5 weeks

Primary Outcome Measures :
  1. Characterization of long-term hearing effects [ Time Frame: 2 years ]
    Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199978

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Contact: Tarin Grillo 617-724-3661

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
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Principal Investigator: Helen A. Shih, MD Massachusetts General Hospital

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Responsible Party: Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital Identifier: NCT01199978     History of Changes
Other Study ID Numbers: 10-218
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by Helen A. Shih, MD, Massachusetts General Hospital:
fractionated proton radiation

Additional relevant MeSH terms:
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Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases