View Clinical Trial (Medical Research Study)
Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Vestibular Schwannoma - Acoustic Neuroma |
| Purpose: |
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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.
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| Study Summary: |
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- Proton radiation will be delivered daily for approximately 6 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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| Criteria: |
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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
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| NCT ID: |
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NCT01199978 |
| Primary Contact: |
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Principal Investigator
Helen A. Shih, MD
Massachusetts General Hospital
Helen A. Shih, MD
Phone: 617-643-7250
Email: hshih@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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