EUCTR2004-001904-10-AT进行中（未招募）不适用
Prospective randomised clinical phase III trial of (alternating IV and oral) vinorelbine plus cisplatin versus docetaxel plus cisplatin in first line chemotherapy of locally advanced or metastatic non-small-cell lung cnacer patients.
Pierre Fabre Médicament represented by IRPF0 个研究点目标入组 350 人开始时间: 2004年11月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Between 18 years and 75 years
- •- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer, stage IIIB (with supra-clavicular or nodal metastases or pleural effusion), stage IV or relapsing (locally or distant) after a local treatment
- •- Karnofsky Performance Status not less than 80%
- •- Life expectancy not less than 12 weeks
- •- Previously untreated with chemotherapy or immunotherapy
- •- Adequate bone marrow, hepatic and renal functions
- •- Presence of at least one measurable indicator lesion (RECIST criteria) which has not been previously irradiated.
- •Are the trial subjects under 18?
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with a local relapse to be treated by radiation therapy only
- •- Symptomatic neuropathy (sensory) not less than 1 according to the NCI Common Toxicity Criteria
- •- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- •- Active central nervous disorder, brain metastasis or leptomeningeal involvment
- •- Weight loss not less than 10% within the previous 3 months
- •- Superior vena cava syndrome
- •- Long term oxygen therapy
- •- Pre-existing symptomatic pleural effusion requiring tapping
- •- Ascites or pericardial effusion
- •- Radiotherapy within the previous 4 weeks
- •- Previous radiotherapy in the only site used to assess response
- •- Concomitant treatment with any other anticancer drug
- •- Known hypersensitivity to drugs with similar chemical structures of study drugs
- •- Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month, given at low doses (not less than 20mg/day of methylprednisolone or equivalent)
- •- Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
- •- Pregnant or breast-feeding women
研究者
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