A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
详细描述
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.
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 verified SCLC, extensive stages
- •WHO performance status 0, 1, 2
- •Age 18 years or older
- •Treatment naive
- •Anticipated survival more than 3 months
- •HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
- •No prognancy
- •Signed informed consent
排除标准
- •Limited stage disease
- •Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
- •Uncontrolled hypertension
- •Uncontrolled heart failure
- •Coagulation problem
- •Surgery, trauma, uncontrolled ulcer in 4 weeks.
- •Required by physician
研究组 & 干预措施
EP chemotherapy
Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide.
干预措施: cisplatin, etoposide (Drug)
EP chemotherapy plus apatinib
Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib.
干预措施: cisplatin, etoposide, apatinib (Drug)
结局指标
主要结局
progression free survival
时间窗: 24 months
from the date of randomization to disease progression
次要结局
未报告次要终点
研究者
medley nie
Secretary of clinical trials
Qingdao University