NCT00633568终止3 期
A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 125
- 试验地点
- 19
- 主要终点
- Survival
研究概览
简要总结
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological or cytological diagnosis of non-small cell carcinoma of the lung
- •Initially unresectable non-metastatic stage III disease
- •Availability for participating in the detailed follow-up of the protocol
- •Presence of an evaluable or measurable lesion
- •Written informed consent
- •No functional or anatomical contraindication to chest irradiation
排除标准
- •Prior treatment with chemotherapy, radiotherapy or surgery
- •Performance status < 60 on the Karnofsky scale
- •History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
- •Neutrophils < 2,000/mm³
- •Platelet cells < 100,000/mm3
- •Serum bilirubin > 1.5 mg/100 ml
- •Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value
- •Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- •Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris
- •Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
- •Uncontrolled infectious disease
- •Symptomatic polyneuropathy
- •Auditive impairment contra-indicating cisplatin administration
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule
- •Malignant pleural or pericardial effusion
- •Homolateral supraclavicular lymph node excepting upper lobe lesion
- •Heterolateral supraclavicular lymph node
- •Known hypersensitivity to docetaxel or cisplatin
- •Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
研究组 & 干预措施
A
Active Comparator
One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
干预措施: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel (Drug)
B
Experimental
Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
干预措施: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel (Drug)
结局指标
主要结局
Survival
时间窗: Survival will be dated from the day of randomisation until death or last follow up
次要结局
- Local control rate(After completion of treatment)
- Response rate(At the end of the whole treatment)
- Toxicity(After each course of chemotherapy and at the end of treatment)
研究者
研究点 (19)
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