A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation
详细描述
In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up
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
- Single (Participant)
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
- •18-75 years old
- •Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
- •The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
排除标准
- •Mismatch conditions above
- •Have used other anti-cancer therapy drug before the trial and may influence the outcome
研究组 & 干预措施
chemotherapy
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
干预措施: Icotinib (Drug)
chemotherapy
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
干预措施: chemotherapy (Carboplatin and Docetaxel) (Drug)
Icotinib
Icotinib, 125mg,3/D,2years
干预措施: Icotinib (Drug)
Icotinib
Icotinib, 125mg,3/D,2years
干预措施: chemotherapy (Carboplatin and Docetaxel) (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: 6 months
次要结局
- Overall survival(6 months)
研究者
Yang Liu
M.D.
Chinese PLA General Hospital