ISRCTN73271276已完成不适用
A randomised phase III study comparing induction chemotherapy to daily low dose Cisplatin both combined with high dose radiotherapy in patients with inoperable non-small cell lung cancer stage I, II and III
etherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (NKI/AVL) and Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 100 人开始时间: 2006年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Pathologically confirmed non-small cell lung cancer (NSCLC)
- •2. Medically inoperable or irresectable NSCLC T 1-4, N0-3, M0
- •3. Age >18 years
- •4. Weight loss <10% in the last 3 months
- •5. FeV1 >0.99l, TLCO >59%
排除标准
- •1. Previous chemotherapy and/or radiotherapy of the chest
- •2. Superior Vena cava syndrome
- •3. Hemoptysis causing a decrease of the blood haemoglobin of >1 mmol/l within 24 hours
- •4. Pleural or pericardial effusion (except if negative cytology)
- •5. Uncontrolled infection
- •6. Maximal length of the esophagus receiving 40 Gy of more than 18 cm, or maximal length of the esophagus receiving 66 Gy of more than 12 cm
- •7. Serious medical risk factors involving any of the major organ systems which may prevent adherence to the treatment schedule
- •8. Patients with pre-existant fibrotic lung disease
- •9. Creatinine clearance <70 ml/min or creatinine >1.25 x normal value
- •10. Bone marrow hypoplasia (Hb 6.8 mmol/l, WBC 4 x 10^9/l, platelets 100 x 10^9/l)
- •11. Recent myocardial infarction(<6 months) or evidence of heart failure
- •12. Impossibility to limit the spinal cord dose to a maximum of 50 Gy
- •13. Impossibility to exclude 2/3 of the heart from the boost volume
研究者
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