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Proton Beam Therapy
Proton Radiation Therapy for Acoustic Neuroma
Phase 2
Waitlist Available
Led By Helen A. Shih, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to tolerate the standard immobilization device that typically utilizes a dental impression mouth piece and thus requires breathing through the nasal passage
No prior radiotherapy with dose delivered to structures in proximity to the internal acoustic canal is allowable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new type of radiation called proton radiation to see if it can better target small tumors while sparing normal surrounding tissues. They will deliver the proton radiation using fractionated stereotactic radiotherapy (FSRT) and will monitor long-term hearing preservation and tumor growth.
Who is the study for?
This trial is for adults with measurable vestibular schwannoma who have 'useful hearing' and a life expectancy over 5 years. They must not have had prior radiotherapy near the internal acoustic canal, be on certain blood pressure medications, or have major ear diseases. Participants need to agree to use contraception and undergo regular hearing tests.Check my eligibility
What is being tested?
The study is testing fractionated proton radiation therapy's ability to preserve hearing in patients with vestibular schwannoma while controlling tumor growth. Proton radiation aims to minimize damage to surrounding tissues compared to conventional therapies.See study design
What are the potential side effects?
Potential side effects may include localized reactions from radiation like skin irritation, fatigue, headaches, hair loss at the treatment site, and possible short-term changes in hearing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can breathe through my nose while using a special device that keeps my head still.
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I have not had radiation therapy near my inner ear.
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I can care for myself but may not be able to do active work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterization of long-term hearing effects
Secondary outcome measures
Delineation of dosimetric parameters after fractionated proton radiation
Impact of Losartan on circulating biomarkers
Impact of Losartan on hearing preservation
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Fractionated Proton RadiationExperimental Treatment2 Interventions
Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan
2003
Completed Phase 4
~3000
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,611 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
Helen A. Shih, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
University Of Pennsylvania School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
1 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can breathe through my nose while using a special device that keeps my head still.Your blood pressure should be above 100 mm Hg when measured while sitting and resting. If it's below 110 mm Hg, we may check the other arm as well. If we check both arms, we'll use the higher value to calculate the average.You have had a bad reaction to radiotherapy in the past.I can lie on my back and rotate as needed for my radiation treatment.My tumor is larger than 3cm.I am not currently taking losartan, any ARB, or ACE inhibitor.I am not taking any medications known to affect hearing.I have not had radiation therapy near my inner ear.I can care for myself but may not be able to do active work.I am 18 years old or older.You are expected to live for more than 5 years.I have had radiotherapy near my inner ear.I've been cancer-free for 5 years or only had certain skin or cervical cancers recently.I am HIV-positive and on combination antiretroviral therapy.You have a specific part of your body that can be accurately measured.You have a significant ear condition like chronic otitis or Meniere's disease.I have a confirmed schwannoma on one side of my head from a recent MRI.I have been diagnosed with neurofibromatosis 2.You must have good hearing in the ear that will receive radiation, as determined by the doctor.I agree to use birth control during my radiation treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Fractionated Proton Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the regulatory agency given their green light to this therapy?
"Based on the Phase 2 trial data we have, this treatment has been given a safety rating of 2. While there is some evidence to support its safety, no clinical proof exists yet that it can effectively treat the condition."
Answered by AI
Does this research initiative have any open enrollment slots?
"According to clinicaltrials.gov, the recruiting window for this medical study has closed and no new participants are being accepted at this time; the trial was initially posted back in March 2011 with its last update taking place on October 31st 2022. Nevertheless, 39 other trials still remain open for enrollment currently."
Answered by AI
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