Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- disease-free survival rate at 1 year
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
详细描述
Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different in earlier stages. There have been no prospective randomized trials to choose an optimal preoperative chemotherapy in early stage NSCLC.
Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in clinical stage IB/II NSCLC.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, pathologically documented NSCLC
- •Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
- •Ages: 15-74 years old
- •ECOG performance status 0 or 1
- •Measurable disease
- •Ample organ function
- •Signed informed consent
排除标准
- •Invasion to the first rib or more superior chest wall
- •Metastasis to, or involvement of, mediastinal node
- •Active concomitant malignancy
- •Unstable angina, recent myocardial infarction, or heart failure
- •Uncontrolled diabetes or hypertension
- •Pregnant or lactating women
- •Other severe complications
- •Systemic use of corticosteroids
研究组 & 干预措施
1
Preoperative docetaxel-cisplatin combination chemotherapy
干预措施: Preoperative docetaxel-cisplatin combination chemotherapy (Drug)
2
Preoperative docetaxel monotherapy
干预措施: Preoperative docetaxel monotherapy (Drug)
结局指标
主要结局
disease-free survival rate at 1 year
时间窗: during the study conduct
次要结局
- pathologic complete response (CR) rate(during the study conduct)
- complete resection rate(during the study conduct)
- post-surgical morbidity/mortality(during the study conduct)
- disease-free survival(during the study conduct)
- treatment compliance(during the study conduct)
- response rate to chemotherapy(during the study conduct)
- overall survival(during the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group