NCT00135161已完成1 期
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
研究概览
简要总结
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).
详细描述
The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
- •Patients who did not undergo surgery for the primary tumor location
- •Patients with a Karnofsky performance score of 70% or more
- •Written informed consent for participation in this trial
排除标准
- •Other malignancy except for non-melanoma skin cancer
- •Prior irradiation to the head and neck region
结局指标
主要结局
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
时间窗: until 3 months after the end of the radiotherapy
Observation of chronic toxicity
时间窗: until 3 months after the end of the radiotherapy
次要结局
- Local control at 2 years(at 2 years)
- Therapy response (2-4 months after end of radiotherapy)(2-4 months after end of radiotherapy)
- Pattern of recurrence(at 2 years)
研究者
研究点 (2)
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