Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 531
- 试验地点
- 15
- 主要终点
- Survival
研究概览
简要总结
The main aim is to determine, in patients with locoregional, non-small cell lung cancer (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of primary tumour, as measured from CT imaging, after adjusting for the effect of the current TNM staging system and other known prognostic factors (especially ECOG performance and weight loss).
详细描述
Patients with locoregional non small cell lung cancer are registered on study after tumour volumes are outlined by a radiologist and prior to the commencement of any treatment.
All patients must have recorded the volume of disease in the primary tumour (and of involved nodes > 1 cm diameter) as measured from a CT scan performed according to a standard set of conditions.
Following registration patients are treated with Definitive radiotherapy with or without chemotherapy. Follow-up will occur with the collection of a minimum amount of data every 12 months from the date of registration on study.
Quality Assurance procedures will be implemented with each site that participates in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must satisfy ALL of the following
- •NSCLC - histological or cytological diagnosis of non-small cell lung cancer
- •Intra-thoracic disease - disease is confined to the primary site, with or without intrathoracic lymph nodes
- •CT planning - CT imaging of the thorax has been performed as part of the planning procedure
- •Definitive radiotherapy - it is planned to give definitive radiotherapy with or without chemotherapy (prior to, during or after radiotherapy). Definitive radiotherapy is defined as 60 Gy in 6 weeks, 50 Gy in 4 weeks or at least the equivalent of either of these. The size of each individual; fraction should not exceed 2.5 Gy.
- •Measurable disease - the primary tumour and nodes with maximum diameter greater than 1cm represent measurable disease
排除标准
- •A patient satisfying ANY of the following is ineligible
- •Symptomatic or radiological evidence of metastatic disease
- •Prior treatment for non-small cell lung cancer
- •Surgical resection is part of initial treatment
- •Palliative radiotherapy planned
结局指标
主要结局
Survival
时间窗: End of Study
Survival duration defined as the time from date of registration until death from any cause
次要结局
未报告次要终点