NCT00148395已完成3 期
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
Aktion Bronchialkarzinom e.V.2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.
It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
- •Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
- •Age between 18 and 75 years
- •Karnofsky index 70 - 100%
- •Measurable or evaluable tumor parameter
- •No prior chemotherapy for NSCLC
- •Sufficient hematological parameter before start of therapy (leucocytes > 3.500/µl and platelets > 100.000/µl).
- •Sufficient liver function (bilirubin < 1,6mg/dl)
- •Sufficient renal function (creatinine < 1,5mg/dl and clearance > 60ml/min)
- •Minimal estimated life expectancy > 3 months
- •Written informed consent for study attendance
- •Patient accessibility for therapy and follow up
- •No attendance to an other study
排除标准
- •Small-cell lung cancer oder tumors with small-cell fractions
- •Local advanced irradiable stage III
- •Previous chemotherapy because of other diseases, not longer than 3 years ago
- •Simultaneous radiation of all present tumor manifestations
- •Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
- •Respiratory insufficiency
- •Heart insufficiency NYHA III and IV
- •Peripheral arteriosclerosis stage III and IV
- •Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol
- •Pregnancy, breastfeeding or not ensured contraception
- •HIV-infection
- •Active hepatitis B and C
- •Manifest infectious diseases before start of therapy
- •Minimal estimated life expectancy < 3 months
- •No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
结局指标
主要结局
Overall survival
次要结局
- Event-free survival
- Quality of live
研究者
研究点 (2)
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