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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
Must not have
Participants with tumors (or residual tumor after surgery) measuring > 3cm in greatest dimension
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor is larger than 3cm.
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I am not currently taking losartan, any ARB, or ACE inhibitor.
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I am not taking any medications known to affect hearing.
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I have had radiotherapy near my inner ear.
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I am HIV-positive and on combination antiretroviral therapy.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterization of long-term hearing effects
Secondary study objectives
Delineation of dosimetric parameters after fractionated proton radiation
Losartan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
3,013 Previous Clinical Trials
13,309,281 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,921 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

Fractionated proton radiation (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01199978 — Phase 2
Acoustic Neuroma Research Study Groups: Fractionated Proton Radiation
Acoustic Neuroma Clinical Trial 2023: Fractionated proton radiation Highlights & Side Effects. Trial Name: NCT01199978 — Phase 2
Fractionated proton radiation (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01199978 — Phase 2
~4 spots leftby Nov 2026
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