NCT03018418进行中（未招募）2 期
A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
Jordan Kharofa1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Rates of Acute Toxicity
研究概览
简要总结
The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Karnofsky Performance Status >70%
- •Histologically documented squamous or basaloid carcinoma of the anal canal
- •Stage T2-4 disease with any N category
排除标准
- •Patients with a life expectancy of < 3 months.
研究组 & 干预措施
Proton Therapy and Chemotherapy
Experimental
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
干预措施: Proton therapy (Radiation)
Proton Therapy and Chemotherapy
Experimental
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Rates of Acute Toxicity
时间窗: 3 months
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
次要结局
- Complete Response Rate(at 6 months from the completion of chemoradiation)
- Rates of Late Toxicity(every 6 months up to 60 months)
- Overall Survival(every 6 months up to 24 months)
- Distant Metastases Free Survival(every 6 months up to 60 months)
- Quality of Life Changes(before treatment and 12 months after start of treatment)
- Local Progression Free Survival(every 6 months up to 60 months)
研究者
Jordan Kharofa
Assistant Professor
University of Cincinnati
研究点 (1)
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