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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated Proton Radiation | Other | Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated proton radiation | Radiation | Given daily for approximately 5.5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of long-term hearing effects | Characterization of long-term hearing effects of fractionated proton therapy in patients with vestibular schwannomas. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate after fractionated proton radiation | 5 years | |
| Delineation of dosimetric parameters after fractionated proton radiation | The distribution of dosimetric parameters will be summarized, and their correlation to clinical outcomes, including hearing loss, will be explored. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen A. Shih, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35229827 | Derived | Saraf A, Pike LRG, Franck KH, Horick NK, Yeap BY, Fullerton BC, Wang IS, Abazeed ME, McKenna MJ, Mehan WA, Plotkin SR, Loeffler JS, Shih HA. Fractionated Proton Radiation Therapy and Hearing Preservation for Vestibular Schwannoma: Preliminary Analysis of a Prospective Phase 2 Clinical Trial. Neurosurgery. 2022 May 1;90(5):506-514. doi: 10.1227/neu.0000000000001869. |
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| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Losartan | Drug | 25mg or 50mg daily, oral administration, for approximately 6 months. |
|
|
| 5 years |
| Incidence of second tumors after fractionated proton radiation | 5 years |
| Toxicity profile of Losartan given concurrently with proton radiation | Toxicities associated with losartan before, during and after proton radiation will be summarized by grade according to CTCAE 4.0. The losartan cohort of 10 participants will provide 90% confidence interval of maximal width +/-27% based on the exact binomial distribution. | 5 years |
| Impact of Losartan on hearing preservation | 5 years |
| Impact of Losartan on circulating biomarkers | 5 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |