Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 671
- 试验地点
- 402
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide.
- Compare the objective response rate and progression-free survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients.
- Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
- Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks.
Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: irinotecan hydrochloride (Drug)
1
干预措施: cisplatin (Drug)
2
干预措施: cisplatin (Drug)
2
干预措施: etoposide (Drug)
结局指标
主要结局
Overall Survival
时间窗: Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.
Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
次要结局
- Confirmed and Unconfirmed Complete and Partial Responses.(Every 6 weeks while on protocol treatment for a maximum of 12 weeks)
- Progression-free Survival(Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.)
- Number of Patients With a Given Type and Grade of Adverse Event.(Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.)