A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The aim of this randomized study is to investigate local tumor control,survival outcomes and complications on patients of liver metastasis in small cell lung cancer.
详细描述
Small cell lung cancer (SCLC) is a kind of disease with high degree of malignancy and poor prognosis.Based on the effectiveness of systemic chemotherapy, the treatment of primary lesions and whole brain radiotherapy can bring survival benefits to patients with extensive stage small cell lung cancer.Patients with liver metastasis have a worse prognosis than those with other organ metastases.Local radiotherapy for patients with liver metastasis may have a better prognosis.However, clinical data of the safety and efficacy of whole liver radiotherapy for liver metastasis are still lacking.The purpose of this prospective study is to evaluate the safety, efficacy, and tolerability of liver metastatic radiotherapy in small cell lung cancer (SCLC).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent (radiation, medication) before treatment;
- •Age 18 to 70 years old,regardless of gender;
- •Initial SCLC confirmed by histopathological or cytological examination;
- •Metastatic lesions in the distant area: included liver metastasis；
- •Physical status score ECOG: 0 to 2；
- •The expected survival time is more than 3 months;
- •Bone marrow function:hemoglobin(HGB)>90g/L,platelet(PLT)>100×109/L,neutrophil cell(WBC)>1.5×109/L(*normal value);
- •Liver function:alanine aminotransferase(ALT) and aspertate aminotransferase(AST)<1.5 times of the upper limit of normal(ULN);Total bilirubin <1.5ULN;
- •Renal function:Serum creatinine was lower than 1.5ULN,and the endogenous creatinine clearance rate(Ccr) is higher than 55mL/min;
- •Initial treatment (previously did not receive any thoracic radiotherapy or surgery).
排除标准
- •patients with history of mental illness;
- •patients combined with other malignancies;
- •Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy;
- •Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias.
- •Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors.
- •History of hepatitis and cirrhosisi ;
- •pregnant, lactating patients;
- •Patients with poor compliance；
- •Researchers believe that it is not appropriate to participate in this test.
结局指标
主要结局
Overall survival (OS)
时间窗: UP to 5years
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Intrahepatic progression -free survial(Intrahepatic-PFS)
时间窗: UP to 5years
Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis.
次要结局
- Progression-free survival(PFS)(UP to 5years)
- Adverse events(toxicities)(UP to 5years)