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Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01199978
First received: September 9, 2010
Last updated: October 22, 2014
Last verified: October 2014
  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 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fractionated Proton Radiation
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 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.
  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 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
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199978

Contacts
Contact: Tarin Grillo 617-724-3661 tgrillo@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: October 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
radiation
fractionated proton radiation

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Ear Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroendocrine Tumors
Neuroma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Peripheral Nervous System Neoplasms
Retrocochlear Diseases
Vestibulocochlear Nerve Diseases

ClinicalTrials.gov processed this record on November 20, 2014