Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
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|ClinicalTrials.gov Identifier: NCT01199978|
Recruitment Status : Recruiting
First Posted : September 13, 2010
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma Acoustic Neuroma||Radiation: Fractionated proton radiation||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Fractionated Proton Radiation
Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects
Radiation: Fractionated proton radiation
Given daily for approximately 5.5 weeks
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199978
|Contact: Tarin Grillofirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Helen A. Shih, MD||Massachusetts General Hospital|