A Phase 2 interventional study of Fractionated proton radiation and Losartan in Vestibular Schwannoma and Acoustic Neuroma, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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.
98 studies on the registry are indexed under Neuroma, Acoustic; 27 are open to participants now.
This study's enrollment of 30 is above the median of 27 across 66 interventional studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects
Radiation: Fractionated proton radiation · Drug: Losartan
Given daily for approximately 5.5 weeks
25mg or 50mg daily, oral administration, for approximately 6 months.
Also known as: Cozaar
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
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital