Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- SUV max from FDG PETScan
研究概览
简要总结
The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.
FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later.
In this study, the investigators propose to perform 4 FDG-PET: first "PET1" before radiotherapy, second "PET2" during the radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the therapy.
The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 non-small cell lung cancer
- •Fertile patients must use effective contraception
- •WHO performance status <2
- •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral CT scan)
排除标准
- •Pregnant or lactating females
- •Baseline fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scan without any target lesion
- •Unable to under PET CT evaluation
- •other concurrent investigational agents
- •No Planning to undergo curative intent radiotherapy
- •familial, social, geographic, or psychological conditions that would preclude study participation
- •Prior malignancy progressive disease
结局指标
主要结局
SUV max from FDG PETScan
时间窗: Baseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwards
Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy
次要结局
- Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy(after the completion enrollment date)