Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)
试验速览
- 阶段
- 3 期
- 入组人数
- 1,108
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer.
The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.
详细描述
It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above.
- •Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
- •The time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks.
- •No evidence of tumor relapse prior to adjuvant therapy.
- •Age 18-70, ECOG performance status 0-
- •Normal hematologic function.Renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, AST and ALT levels below 1.5 times of normal value.
- •No history of chemotherapy or radiotherapy;
- •The patient should have well compliance for chemotherapy and follow up.Informed consent should be obtained before treatment.
排除标准
- •The histological or cytological documents do not match the inclusion criteria.
- •Right side pneumonectomy or any kind of incompletely resected surgery.
- •The recruitment time are beyond 8 weeks from surgery.
- •Any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. The researchers can make a judge for the following conditions to tell whether they are fit for this research:Uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.Evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.Clinically significant active infection state due to bacteria, virus and fungi invasion. Patients with grade II arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade II high blood pressure or left ventricle ejection fraction (LVEF) less than 50 percent according to CTC 3.0 are not permitted to enrol the study.
- •women with pregnant or lactation.
- •Before enter the group,the patients had other malignant tumors except for non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.
- •With allergic constitution or possible allergic reflection to any known research drugs.
- •Poor compliance.
- •Not proper for the research according to the researchers' judgment.
研究组 & 干预措施
A
vinorelbine plus cisplatin plus recombinant human endostatin
干预措施: recombinant human endostatin (Drug)
B
vinorelbine plus cisplatin
干预措施: recombinant human endostatin (Drug)
结局指标
主要结局
overall survival
时间窗: five year
次要结局
- recurrence-free survival and the toxicity and safety of the regimens(5 year)