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NCT01199978 · ClinicalTrials.gov registry record · Phase 2
Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma
A Phase 2 study of Vestibular Schwannoma and Acoustic Neuroma, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01199978: Active Phase 2 study of Vestibular Schwannoma and Acoustic Neuroma, sponsored by Massachusetts General Hospital.
NCT01199978 is a Phase 2 study of Vestibular Schwannoma and Acoustic Neuroma that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 48-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01199978, a Phase 2 study of Vestibular Schwannoma and Acoustic Neuroma, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas.
Conditions Studied
Interventions
- DRUG Losartan
- RADIATION Fractionated proton radiation
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03-08 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT01199978 still lists
NCT01199978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 48-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (37% lower).
The record links to 2 conditions, with Vestibular Schwannoma appearing as the primary indexed condition, and to 2 interventions - of which Losartan is the first listed.
NCT01199978 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01199978 about?
NCT01199978 is a clinical study titled "Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma". 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. ...
What is the current status of trial NCT01199978?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-03-08. Estimated completion is 2026-11.
What conditions does trial NCT01199978 study?
This clinical trial studies the following conditions: Vestibular Schwannoma, Acoustic Neuroma.
What interventions are being tested in trial NCT01199978?
The interventions under investigation include: Losartan (DRUG), Fractionated proton radiation (RADIATION).
Who is sponsoring clinical trial NCT01199978?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01199978 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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