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Clinical Trial Finder

Search Results

Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 at the discretion of the treating physician in the irradiated ear.
  • - 18 years of age or older.
  • - Life expectancy of greater than 60 months.
  • - Karnofsky performance status 60 or greater.
  • - Diagnosis of neurofibromatosis 2 (NF2) is permitted.
  • - 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.
  • - Able to tolerate the standard immobilization device that typically utilizes a dental impression mouth piece and thus requires breathing through the nasal passage.
  • - 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.
  • - Baseline Systolic Blood Pressure (BP) > 100mm Hg.
This is based on the average of two values
  • - separate seated, resting measurements taken five minutes apart.
BP does not need to be checked in both arms unless a reading is below 110 mm Hg, in which case the other arm can be checked as well. If BP is checked in both arms, the higher value is deemed accurate for calculating the average.

Exclusion Criteria:

  • - Participants who have had prior radiotherapy, with dose delivered to structures in proximity to the internal acoustic canal (IAC).
  • - Participants with tumors (or residual tumor after surgery) measuring > 3cm in greatest dimension.
  • - Participants may not be receiving any other study agents.
  • - History of adverse reaction to radiotherapy.
  • - Participants may not already be on losartan, other angiotensin II type I receptor blocker (ARB), or on an angiotensin-converting enzyme (ACE) inhibitor prior to enrollment of this study.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01199978
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Helen A. Shih, MD
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Vestibular Schwannoma, Acoustic Neuroma
Additional Details

  • - 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.

Arms & Interventions

Arms

Other: Fractionated Proton Radiation

Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects

Interventions

Radiation: - Fractionated proton radiation

Given daily for approximately 5.5 weeks

Drug: - Losartan

25mg or 50mg daily, oral administration, for approximately 6 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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