Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Photon intensity modulated radiation therapy (IMRT)
* Radiation: Proton beam radiotherapy (PBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18. Histopathologically confirmed diagnosis of one the following cancer types: Salivary gland cancer Skin cancer Melanoma 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: Any prior head or neck irradiation. Physician recommendation of bilateral neck radiation. Non-resectable disease Physician recommendation of mucosal radiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photon intensity modulated radiation therapy (IMRT)<br>IMRT to standard dose of 60-66Gy | Radiation: Photon intensity modulated radiation therapy (IMRT)<br>* Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.<br>|
| Experimental: Proton beam radiotherapy (PBRT)<br>PBRT to standard dose of 60-66Gy | Radiation: Proton beam radiotherapy (PBRT)<br>* Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with grade 2 or greater acute mucositis | via the CTCAE v4.0. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proton-beam radiation therapy (PBRT), intensity-modulated radiation therapy (IMRT), 16-1416