跳至主要内容
临床试验/NCT00797043
NCT00797043终止不适用

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion

University of Florida1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)

研究概览

简要总结

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

详细描述

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

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

入选标准

  • Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
  • Biopsy-proven squamous cell carcinoma.
  • 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 grade 3 or higher xerostomia (dry mouth)

时间窗: 1 year following the completion of radiation therapy

次要结局

  • Collect and analyze tumor control outcomes.(When each patient has been followed for a minimum of 6 months and then again at 24 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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