NCT00349492已完成3 期
Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)
Clinical Research Center for Solid Tumor, Korea14 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 14
- 主要终点
- Overall survival
研究概览
简要总结
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years
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
- •Histologically or cytologically diagnosed small cell lung cancer
- •Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
- •If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
- •No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
- •One or more measurable disease by RECIST criteria
- •at least 18 years of age
- •Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria
- •Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function
- •Informed consent from patient which conforms to Institutional Review Board
排除标准
- •History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
- •Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- •Uncontrolled serious infection
- •Enrollment in other study within 30 days
研究组 & 干预措施
EP
Active Comparator
etoposide + cisplatin
干预措施: IP (Drug)
结局指标
主要结局
Overall survival
时间窗: month
次要结局
- Objective response rate(percent)
- Progression free survival(month)
- Safety profile(percent)
研究者
Hyeong-Seok Lim
Dae Seog Heo, professor
Clinical Research Center for Solid Tumor, Korea
研究点 (14)
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