NCT00797446终止不适用
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Collect and analyze morbidity outcomes: incidence of xerostomia
研究概览
简要总结
The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.
详细描述
This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
- •Stage-grouping:
- •Stage I (T1N0)
- •Stage II (T2N0)
- •Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
- •Unfavorable stage III and selected stage IV (any T, N2c/N3)
- •Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
- •Will receive treatment with proton radiation.
排除标准
- •Evidence of distant metastasis.
- •Previous irradiation for head and neck cancer.
结局指标
主要结局
Collect and analyze morbidity outcomes: incidence of xerostomia
时间窗: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
次要结局
- Collect and analyze tumor control outcomes.(From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
研究点 (1)
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