Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. Radiotherapy is an important treatment strategy for advanced non-small cell lung cancer. However patients have different responses to radiotherapy due to individual differences, thus there is still lacking of sensitive markers to predict treatment response at present. Using bioinformatics to process the data and small sample clinical trial, our previous study found 5 plasma miRNAs were related to radiosensitivity. The design is controlled clinical trial. According to the size of lung lesions, the investigators divided the patients into hyperfractionated radiotherapy group（50Gy/11F/2W) with lesion ≤5cm in diameter and conventional fractionated radiotherapy group（60Gy/30F/6W）with lesion >5cm in diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological histology and/or cytology confirmed NSCLC;
- •Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
- •Expected survival > 3 months;
- •Age 18~75 years old;
- •The function of lung, liver, kidney, bone marrow was normal;
- •The patients had not received radiotherapy for previous primary tumor and metastases;
- •At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
- •Wild-type EGFR;
- •Sensitive mutant EGFR, but refused to targeted therapy;
- •In line with the indications of radiotherapy and accept it;
- •Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
排除标准
- •Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
- •Patients with other malignancies;
- •Patients with a history of autoimmune disease;
- •The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
- •In the activity of acute or chronic infectious diseases;
- •Patients with a clear history of drug allergy or allergic genus;
- •Patients with participating in other clinical trials at the same time;
- •Other cases that researchers believe that patients should not participate in the present trial.
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: up to two and a half years
次要结局
- Progression free survival（PFS）(up to two and a half years)
- Correlation between the expression level of miRNAs and the ORR.(up to two and a half years)
- side effects of radiation(up to two and a half years)
研究者
Jianguo Sun
Deputy director
Xinqiao Hospital of Chongqing