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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Experimental | IMRT to standard dose of 60-66Gy |
|
| Proton beam radiotherapy (PBRT) | Experimental | PBRT to standard dose of 60-66Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Radiation | Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with grade 2 or greater acute mucositis | via the CTCAE v4.0. | 1 year |
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Inclusion Criteria:
Age greater than or equal to 18.
Histopathologically confirmed diagnosis of one the following cancer types:
HNSCC that require ipsilateral radiation
Patients must be a candidate for ipsilateral radiation therapy.
Karnofsky performance status ≥70.
Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lee, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Alliance MCI | Miami | Florida | 33143 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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This is a phase II randomized two-arm trial comparing proton-beam radiation therapy (PBRT) with photon- based intensity-modulated radiation therapy (IMRT) for cancers in the head and neck region requiring ipsilateral radiation.
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| Proton beam radiotherapy (PBRT) | Radiation | Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction. |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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