The Randomized Controlled Clinical Trial of Kushen Injection Reducing Radiotherapy Related Adverse Reactions in Lung Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The rates of incidence and the degree of adverse reactions caused by redioterapy
研究概览
简要总结
The randomized controlled multicenter clinical study of compound Kushen Injection to reduce the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials，The main purpose is to evaluate the effect of compound Kushen Injection in preventing and reducing the radiotherapy related adverse reactions. The participants of the clinical trials are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group of participants is given compound Kushen Injection with chemoradiotherapy, while another group is only given chemoradiotherapy. The period of trials is 18 months.
详细描述
Patients with lung cancer who need thoracic radiotherapy will be enrolled in the trial, then seprated randomly in two group,the KS injection group treated with chemoradiotherapy plus KS injection; the contral group treated with chemoradiotherapy only. After 6 months observation, The rates of incidence and the degree of adverse reactions caused by redioterapy; the completion rate of radiotherapy; clinical Symptoms; Qof and pulmonary function tests etc. will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent
- •To be aged from 18 to 75 years old, both gender
- •The lung cancer diagnosis must be proved by pathology
- •According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm)
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Lung function FEV1 more than at least 1Land more than 50% A normal value
- •The function of each organ is basically normal :ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN(less than 5*ULN, if with liver metastases), SCr less than 1.5*ULN
- •The expected survival tme must more than 6 months.
排除标准
- •Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks
- •Pregnancy or lactation women
- •Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - Participating or within the last 30 days participated in other clinical trials
- •Hypersensitiveness to any kind of trial regime
- •Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence
- •Estimating the compliance of patients to participate in this clinical trial is insufficient.
研究组 & 干预措施
KS injection arm
Radiation and chemotherapy and compound Kushen Injection
干预措施: Compound Kushen Injection (Drug)
结局指标
主要结局
The rates of incidence and the degree of adverse reactions caused by redioterapy
时间窗: 6 months
radio-pulmonary lesion,radiation esophagitis,Radiation Induced Heart Disease
次要结局
- The completion rate of radiotherapy(2 months)
- Clinical Symptoms (MDASI-TCM)(6 months)
- Quality of Life (EORTC QLQ-C30)(6 months)
- ECOG PS (ECOG PS score)(6 months)
- Weight(6 months)
- Gene molecule detection (EGFR)(4 weeks)
- Pulmonary function tests (FEV1,FVC,DLCO)(6 months)
- Immune function (Observation indexes including NK、T lymphocyte subpopulation（CD3、CD4、CD8）、CD4/CD8)(6 months)