A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 37
- 主要终点
- overall survival
研究概览
简要总结
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
详细描述
The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cytologically, histologically proven small-cell lung cancer
- •limited disease
- •age 20-70 years old
- •performance status of 0-1
- •measurable disease
- •no prior treatment for small-cell lung cancer
- •no history of chemotherapy
- •adequate organ functions
- •written informed consent
排除标准
- •pericardial effusion
- •active concomitant malignancy
- •pregnant or lactating women
- •interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
研究组 & 干预措施
1
Etoposide and cisplatin after chemoradiotherapy
干预措施: Etoposide and cisplatin after chemoradiotherapy (Drug)
2
Irinotecan and cisplatin after chemoradiotherapy
干预措施: Irinotecan and cisplatin after chemoradiotherapy (Drug)
结局指标
主要结局
overall survival
时间窗: during the study conduct
次要结局
- adverse events of induction chemoradiotherapy(during the study conduct)
- late radiation morbidity(during the study conduct)
- serious adverse event(during the study conduct)
- chemotherapy after chemoradiotherapy(during the study conduct)
- progression-free survival(during the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group