NCT01426841Unknown1 期
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
研究概览
简要总结
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
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
- •patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- •chest-confined disease (including bulky intrathoracic disease)
- •adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
- •patients of childbearing potential must practice adequate contraception
- •Age > or = 18 years
- •Karnofsky performance status > or = 70
- •eligible for concurrent chemoradiotherapy
排除标准
- •patients who have undergone complete or subtotal tumour resection
- •evidence of non-small cell histology
- •prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- •prior RT to the thorax or neck
- •compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
- •pregnant women
结局指标
主要结局
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
时间窗: 12-24 months
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
次要结局
- Survival(12-24 months)
- Local control and patterns of failure(12-24 months)
研究者
研究点 (2)
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