Phase 2 Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Time to Disease Progression
研究概览
简要总结
Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. The objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. The investigators will use the peripheral blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of small cell lung cancer
- •Extensive stage according to American Veteran Staging System
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1
- •Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2
- •Age≥18 years
- •Adequate organ function
- •Consent form according with Guideline for Good Clinical Practice of the International Conference on Harmonisation (ICH-GCP)guidelines
- •The expected survival≥2 months
排除标准
- •Pathological diagnosis of mixed small cell lung cancer
- •Limited stage according to American Veteran Staging System
- •Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator
- •Known pre-existing interstitial lung disease
- •Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator
- •Any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator
- •Pregnant or lactating women
- •Active phase of hepatitis B virus infection,Active phase of hepatitis C virus infection or known HIV carriers
研究组 & 干预措施
etoposide,maintenance therapy
etoposide,25mg qd d1-20，repeat every 28 days
干预措施: Etoposide (Drug)
结局指标
主要结局
Time to Disease Progression
时间窗: up to 12 months
次要结局
未报告次要终点
研究者
Jie Wang
Chief of thoracic cancer department
Peking University Cancer Hospital & Institute