Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01199978
First received: September 9, 2010
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vestibular Schwannoma Acoustic Neuroma |
Radiation: Fractionated proton radiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Characterization of long-term hearing effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas.
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Proton radiation therapy
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
|
Detailed Description:
- Proton radiation will be delivered daily for approximately 6 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- MRI confirmed unilateral vestibular schwannoma within 8 weeks prior to study entry
- Measurable disease, defined as a lesion that can be accurately measured in at least one dimension
- No prior radiotherapy with dose delivered to structures in proximity to the internal acoustic canal is allowable
- Participants must have baseline "useful hearing" defined as having hearing loss no greater than grade 2 in the irradiated ear
- 18 years of age or older
- Life expectancy of greater than 60 months
- Karnofsky performance status 60 or greater
- Women of child-bearing potential and men must agree to use adequate contraception during the interval of irradiation
- Able to tolerate the supine position as required for the radiation treatment unit and able to tolerate rotation needed for treatment delivery
- Willing and able to comply with comprehensive audiologic testing, at baseline prior to radiation therapy, at 6 months from treatment completion, and at annual timepoints for 5 years after completion
Exclusion Criteria:
- Participants who have had prior radiotherapy, with dose delivered to structures in proximity to the internal acoustic canal
- Participants with tumors (or residual tumor after surgery) measuring > 3cm in greatest dimension
- Participants with neurofibromatosis type 2 (NF2)
- Participants may not be receiving any other study agents
- History of adverse reaction to radiotherapy
- Participants receiving any medications or substances that are known to cause ototoxicity are ineligible
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women
- Individuals with a history of malignancy are ineligible except for the following circumstances. Individuals with a history of malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be a low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell squamous cell carcinoma of the skin.
- HIV-positive individuals on combination antiretroviral therapy
- Patients with co-existing major ear disease, such as chronic otitis, Menieres disease, or otosclerosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199978
Contacts
| Contact: Helen A. Shih, MD | 617-643-7250 | hshih@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Helen A. Shih, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01199978 History of Changes |
| Other Study ID Numbers: | 10-218 |
| Study First Received: | September 9, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
radiation fractionated proton radiation |
Additional relevant MeSH terms:
|
Neurilemmoma Neuroma Neuroma, Acoustic Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms by Site Cranial Nerve Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on June 18, 2013