Determination of the Predictive Value of FDG-PET-CT Scans, Blood Proteins and Blood Cells for the Prognosis for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy
研究概览
简要总结
The objective of the study is to investigate the evolution ofn 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with lung cancer of during and after concurrent radiotherapy and chemotherapy
详细描述
This translational research part is aiming to give more insights in the way radiation injury and tumour response develops.
It involves three parts:
- Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.
- Blood sampling before, during and after radiotherapy in order to find predictors for normal tissue injury and for tumour response.
- Extra staining of tumour biopsies
The FDG-PET-CT scan with i.v. contrast gives information of the tumour metabolism and its morphology. Therefore, one extra FDG-PET-CT scans will be done during radiotherapy at day 8. Tumour response will be determined by FDG-PET-CT scans 3 months after radiotherapy.
Blood samples
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histological proven non-small cell or small cell lung cancer UICC stage I-III (in case of small cell lung cancer: limited stage)
- •WHO performance status 0-2
- •Less than 10 % weight loss the last 6 months
- •In case of previous chemotherapy, concurrent chemo-radiotherapy can start after a minimum of 21 days after the last chemotherapy course
- •No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- •No active peptic oesophagitis
- •Life expectancy more than 6 months
- •Measurable cancer
- •Willing and able to comply with the study prescriptions
- •18 years or older
- •Not pregnant and willing to take adequate contraceptive measures during the study
- •Have given written informed consent before patient registration
- •No previous radiotherapy to the chest
排除标准
- •Not non-small cell or small cell histology, e.g. mesothelioma, lymphoma
- •Malignant pleural or pericardial effusion
- •History of prior chest radiotherapy
- •Recent (< 3 months) myocardial infarction
- •Uncontrolled infectious disease
- •Distant metastases (stage IV)
- •Patients with active peptic oesophagitis in the last year
- •Less than 18 years old
- •Pregnant or not willing to take adequate contraceptive measures during the study
结局指标
主要结局
Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy
时间窗: 9 months post-radiation
次要结局
- - Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation(9 months post-radiation)