Phase ⅡTrial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage Ⅱ-ⅢA Non-small Cell Lung Cancer (NSCLC) After Complete Resection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival rate
研究概览
简要总结
The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.
详细描述
Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.
For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.
S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)
- •Must be able to receive the therapy of the study within four weeks after the completely resection
排除标准
- •Systemic anticancer treatment
- •local radiotherapy
研究组 & 干预措施
S1 capsule plus Cisplatin
S1: 40mg, bid, when body surface area (BSA)<1.25 m2, 50mg; bid when 1.25 m2≤BSA<1.5 m2; 60mg, bid when 1.5 m2≤BSA 60mg from day 1 to 14. Cisplatin: 75 mg/m2 on day 1.
3 weeks/4cycles
干预措施: S1 capsule (Drug)
Vinorelbine plus Cisplatin
Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1.
3 weeks/4cycles
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Disease free survival rate
时间窗: 2 years
次要结局
- Disease free survival(4 years)
- Overall survival(4 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.)
- Quality of life (QOL)(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.)