NCT01199978

Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vestibular Schwannoma
• Acoustic Neuroma

Interventions

Type	Name	Description
RADIATION	Fractionated proton radiation	Given daily for approximately 5.5 weeks
DRUG	Losartan	25mg or 50mg daily, oral administration, for approximately 6 months.

Timeline

• Start date: 2011-03-08
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2010-09-13
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study