Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The progression-free survival in this population of patients
研究概览
简要总结
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
详细描述
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed patients with extensive small cell lung cancer;
- •Karnofsky performance status ≥60;
- •At least one lesion that can measured by CT;
- •Expected to survive for at least 3 months;
- •Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
- •White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L;
- •Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit;
- •Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent
- •Must be able to swallow tablets
排除标准
- •Limited stage disease
- •Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
- •Other pathological types of tumor except for small cell lung cancer;
- •Patients with a history of severe allergies or allergies;
- •Pregnancy or breastfeeding women;
- •Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- •Patients who have acute infection that difficult to control;
- •Subjects with difficulties in swallowing or known drug malabsorption.
研究组 & 干预措施
experimental arm
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
干预措施: cis Platinum, etoposide, S1 (Drug)
active comparator
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
干预措施: cis Platinum, etoposide, S1 (Drug)
结局指标
主要结局
The progression-free survival in this population of patients
时间窗: 2.5 years
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
次要结局
- The overall survival in this population of patients.(2.5 years)
- Percentage of Participants Experiencing an Adverse Event (AE)(2.5 years)