NCT02923570进行中（未招募）2 期
A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 17
- 主要终点
- number of patients with grade 2 or greater acute mucositis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to
- •Histopathologically confirmed diagnosis of one the following cancer types:
- •Salivary gland cancer
- •Skin cancer
- •HNSCC that require ipsilateral radiation
- •Patients must be a candidate for ipsilateral radiation therapy.
- •Karnofsky performance status ≥
- •Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.
排除标准
- •Any prior head or neck irradiation.
- •Physician recommendation of bilateral neck radiation.
- •Non-resectable disease
- •Physician recommendation of mucosal radiation
研究组 & 干预措施
Photon intensity modulated radiation therapy (IMRT)
Experimental
IMRT to standard dose of 60-66Gy
干预措施: Photon intensity modulated radiation therapy (IMRT) (Radiation)
Proton beam radiotherapy (PBRT)
Experimental
PBRT to standard dose of 60-66Gy
干预措施: Proton beam radiotherapy (PBRT) (Radiation)
结局指标
主要结局
number of patients with grade 2 or greater acute mucositis
时间窗: 1 year
via the CTCAE v4.0.
次要结局
未报告次要终点
研究者
研究点 (17)
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