跳至主要内容
临床试验/NCT06550518
NCT06550518已完成不适用

Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study

University Hospital, Brest3 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
3
主要终点
Progression-free survival

研究概览

简要总结

Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.

In this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (age ≥18 years)
  • Histologically or cytologically SCLC diagnosis
  • Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020

排除标准

  • Opposition to participate registered
  • Patients under legal protection
  • Patients afflicted by another subtype of lung carcinomas
  • SCLC not treated with the epirubicin-paclitaxel doublet

结局指标

主要结局

Progression-free survival

时间窗: through study completion, an average of 1 year

Time from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause

次要结局

  • Overall survival(1 year)
  • Objective response rate(1 year)
  • Intracranial control rate(1 year)
  • Disease control rate(1 year)
  • Toxicities(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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