Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma (NCT01199978) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
United States30 participantsStarted 2011-03-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.