Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-Free Survival in the first line of chemotherapy
研究概览
简要总结
This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first line treatment.
详细描述
According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21 days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •aged 18 to 70 years old, men and women are not limited;
- •confirmed by histopathological examination SCLC;
- •clinical stage for patients with extensive stage (except for the case of pleural effusion)
- •patients has no drug treatment history
- •the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days.
- •there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation;
- •physical condition score ECOG PS:0-1
- •more than expected survival time over 3 months
排除标准
- •the previous platinum compounds have a history of allergies;
- •active ulcer patients;
- •Patients with primary lung lesions were treated with radiotherapy;
- •chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis;
- •the need for treatment of brain metastases in the active phase
- •there are more serious tumor invasion, superior vena cava syndrome, or in the middle volume of malignant pleural effusion, abdominal effusion or pericardial effusion, not yet control;
- •there is a serious infection, ADH abnormal secretion syndrome, poor control of diabetes,the need for the treatment of patients with severe complications such as vena cava syndrome
研究组 & 干预措施
temozolomide maintain therapeutic
Lobaplatin combined with etoposide for first-line treatment of extensive stage small cell lung cancer,then clinical benefit patients for temozolomide maintain therapeutic.This study have only one arm which temozolomide maintain at dose of 150mg/m2 D1-5 Q4W.
干预措施: temozolomide (Drug)
结局指标
主要结局
Progression-Free Survival in the first line of chemotherapy
时间窗: 6 months
The first day of treatment to the date that disease progression is reported
次要结局
- Overall Survival (OS)(3 years)
- Tumor Response Rate (RR)(3 months)
- Treatment-related adverse events(the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months)
研究者
Yunpeng Liu
Director, clinical research
China Medical University, China