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.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Given daily for approximately 5.5 weeks
25mg or 50mg daily, oral administration, for approximately 6 months.
Massachusetts General Hospital
Boston, Massachusetts, United States
Characterization of long-term hearing effects
Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas.
Time frame: 5 years
Local control rate after fractionated proton radiation
Time frame: 5 years
Delineation of dosimetric parameters after fractionated proton radiation
The distribution of dosimetric parameters will be summarized, and their correlation to clinical outcomes, including hearing loss, will be explored.
Time frame: 5 years
Incidence of second tumors after fractionated proton radiation
Time frame: 5 years
Toxicity profile of Losartan given concurrently with proton radiation
Toxicities associated with losartan before, during and after proton radiation will be summarized by grade according to CTCAE 4.0. The losartan cohort of 10 participants will provide 90% confidence interval of maximal width +/-27% based on the exact binomial distribution.
Time frame: 5 years
Impact of Losartan on hearing preservation
Time frame: 5 years
Impact of Losartan on circulating biomarkers
Time frame: 5 years
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