EUCTR2006-003995-36-IT进行中（未招募）1 期
A MULTICENTER RANDOMIZED PHASE III STUDY COMPARING FIXED DOSES WITH TOXICITY-ADJUSTED DOSES OF STANDARD CHEMOTHERAPY WITH CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY ADVANCED SMALL CELL LUNG CANCER - STAD-1
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点目标入组 160 人开始时间: 2007年6月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Cytologic or hystologic diagnosis of SCLC; Extended stage of disease; at least one target lesion; Performance status (ECOG) 0 - 1; age < 70 years; written informed consent
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previuos chemotherapy; previous or concomitant malignancy; Neutrophils < 1.5 x 109/L, platelets < 100 x 109/L, and hemoglobin < 10 g/dL; Bilirubin level either normal or > 1.5 x ULN; AST (SGOT) and ALT (SGPT)> 2.5 x ULN; Serum creatinine > 1.5 x ULN; hypersensitivity to darbepoetin alfa, r-HuEPO or any inactive ingredients; uncontrolled hypertension.
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