Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- development and validation of a multi-variate predictive model
研究概览
简要总结
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.
The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers
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
- •Proof of cT1a/b - 2a/b N0M0 NSCLC
- •Informed Consent signed
- •Resectable tumour
- •> 18 years old
- •men and women
排除标准
- 未提供
结局指标
主要结局
development and validation of a multi-variate predictive model
时间窗: from 2 to 5 years
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
次要结局
- the clinical response and complication rate(from 2 to 5 years)
- local, regional or distant failure(from 2 to 5 years)
- progression free survival(from 2 to 5 years)
- disease specific overall survival(from 2 to 5 years)