Clinical Trial: Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

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.

Detailed Summary:

  • 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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: September 9, 2010
Date Started: September 2010
Date Completion: September 2017
Last Updated: December 20, 2016
Last Verified: December 2016