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临床试验/NCT00938418
NCT00938418Unknown2 期

Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2009年7月最近更新:
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

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

申办方类型
Other

研究点 (2)

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