Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 主要终点
- progress free survival
研究概览
简要总结
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol
详细描述
Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer
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
- •Histologically confirmed oral squamous-cell carcinoma
- •Age > 17 years
- •Signed informed consent
- •ECOG Performance status 0-2
- •Must be able to start RT within 4 weeks after PET/CT simulation
排除标准
- •stage IV disease diagnosed before acquisition of staging PET/CT
- •prior radiotherapy to oral and neck
- •Unable to understand study participation
- •Claustrophobia
- •pregnant or breast feeding mothers
结局指标
主要结局
progress free survival
时间窗: baseline to 2 years
次要结局
未报告次要终点
研究者
yahua zhong
Director,oncology , Principal Investigator, Clinical Professor
Zhongnan Hospital