NCT00938418Unknown2 期
Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.
This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.
This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.
排除标准
- •Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
- •Greater than minimal, exudative, or cytologically positive pleural effusions
- •≥ 10% weight loss within the past month
- •Prior invasive malignancy (with exceptions)
- •Prior radiotherapy to the region of the study cancer
- •Significant co-morbidities
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Known allergic reactions to components of planned chemotherapy regimen
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Response rate, locoregional control, disease free survival, toxicity(2 years)
研究者
研究点 (2)
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