NCT02039518Unknown2 期
Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
详细描述
from the first cycle of treatment (day one) to two month after the last cycle
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
- •Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer
- •Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD
- •Expected lifetime>12 weeks
- •Signed written informed consent
排除标准
- •Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of >CTCAE caused tumor treatment past grade 2 toxicity Ccr<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency：
- •Tbil> 1.5×ULN
- •ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
- •Severe symptomatic heart disease
- •Symptomatic brain metastases
- •In the last 5 years have been or are suffering from other histological types of malignant tumor
- •There are serious or uncontrolled systemic diseases
- •During the study period planned radiotherapy on target lesion
- •During the study period, plans to use other antineoplastic therapy
- •Clinical study on treatment of 30 days beginning period prior to participate in any study drug
研究组 & 干预措施
observation group
Other
observation
干预措施: observation group (Other)
gemcitabine
Experimental
gemcitabine 1000mg/m2，d1，d8，Q3W
干预措施: gemcitabine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
未报告次要终点
研究者
Xianghua Wu
Associate Chief Physician
Fudan University
研究点 (1)
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