Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
详细描述
Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer.
The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged.
The primary end point is: Objective response rate;
The secondary end points are:
- progression-free survival(PFS);
- overall survival(OS);
- Time to Progression (TTP);
- quality of life questionnaire（QOL);
- other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC
- •Ages Eligible for Study: 18-65 years old;
- •Physical status score (ECOG PS) ≤ 2 scores；
- •Estimated life expectancy of at least 6 months；
- •Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥80*109/L, Liver and kidney function is normal;
- •Informed consent from the patient.
排除标准
- •Patient with other malignant tumor except NSCLC 5 years previous to study entry.
- •Patients who have received targeted drug treatment；
- •Serious problem of heart, liver or kidney with severe dysfunction;
- •Pregnant or child breast feeding women;
- •Mental or cognitive disorders;
- •Participating in other drug trials;
- •Who are allergic to the study drug.
- •Diabetic patients.
研究组 & 干预措施
chemotherapy
Eligible subjects will be treated with platinum-doublet 2 cycles chemotherapy:pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin. Each cycle was 21-days.
Dosage:pemetrexed i.v.500mg/m2 d1 ; docetaxel i.v.75mg/m2 d1 ; gemcitabine i.v.1250 mg/m2 d1,d8 ; paclitaxel i.v.175mg/m2 d1 ; vinorelbine i.v.25mg/m2 d1,d8; carboplatin i.v.area under curve (AUC) 5 d1 ；cis-platinum i.v.75mg/m2 d1（or divided into 3days）；nedaplatin i.v.80mg/m2 d1.
干预措施: pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin (Drug)
TCM combined chemotherapy
TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21
干预措施: JinFuKang (Drug)
TCM combined chemotherapy
TCM：JinFuKang plus XingZaoRuanJian, chemotherapy will be the same. JinFuKang po.tid.30ml d6-d21 XingZaoRuanJian po.tid.30ml d6-d21
干预措施: XingZaoRuanJian (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months
The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer.
次要结局
- Time-to-Progression(up to 2 months)
- Number of participants with treatment-related quality of life as assessed by FACT-L4.0(21 days)
- Objective response rate(up to 2 months)