Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- pathological effects of hypofractionated radiation therapy
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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.
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
- •Operable patient
- •> 18 years old
- •men and women
排除标准
- 未提供
结局指标
主要结局
pathological effects of hypofractionated radiation therapy
时间窗: at 2 years
To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.
次要结局
- clinical response rate(from 2 to 5 years)
- progression free survival(from 2 to 5 years)
- overall survival(from 2 to 5 years)
- the accuracy of clinical mediastinal staging(from 2 to 5 years)
- the complication rate(from 2 to 5 years)
- local, regional or distant failure(from 2 to 5 years)
- disease specific overall survival(from 2 to 5 years)