A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of acute dose limiting toxicities
研究概览
简要总结
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
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
- •Recurrent or second primary squamous cell head and neck cancer
- •Defined area of recurrence on imaging
- •Previous head and neck radiation (RT) to >/= 50 Gy
- •Performance status score 0-1
- •Time interval from previous RT >/= 9 months
- •Volume of disease appropriate for protocol treatment
- •Minimum estimated survival of >/= 3 months
- •Age >/= 18
- •Adequate labs
排除标准
- •Primary tumors of the salivary gland
- •Original pathology report and radiation therapy records not available
- •Prior spinal cord dose > 45 Gy
- •Surgery or chemotherapy within 4 weeks
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
研究组 & 干预措施
Docetaxel + Stereotactic Radiation
Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours.
干预措施: Docetaxel (Drug)
Docetaxel + Stereotactic Radiation
Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours.
干预措施: Stereotactic Radiation (Radiation)
结局指标
主要结局
Number of acute dose limiting toxicities
时间窗: 3 months
Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture
次要结局
- Locoregional control(2 years)
- Disease-free survival(2 years)
- overall survival(2 years)
- Number of late effect dose limiting toxicities(2 years)