跳至主要内容
临床试验/NCT03590275
NCT03590275已完成不适用

Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX

Azienda Ospedaliero, Universitaria Pisana7 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2017年10月2日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
343
试验地点
7
主要终点
Overall survival

研究概览

简要总结

The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.

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

  • age >18 years
  • citologically or histologically confirmed pancreatic carcinoma
  • disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system
  • access to clinical informations collected before first-line starting
  • availability of objective response evaluation and survival data
  • written informed consent

排除标准

  • diagnosis of other neoplasia than pancreatic carcinoma
  • treatment with drugs other than FOLFIRINOX
  • treatment with experimental drugs in combination with FOLFIRINOX
  • unavailability of clinical and pathological data

结局指标

主要结局

Overall survival

时间窗: up to 2 years

Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.

次要结局

  • Progression-free survival(up to 2 years)
  • Response rate(up to 2 years)
  • Toxicity rate(up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo Falcone

Prof. Alfredo Falcone

Azienda Ospedaliero, Universitaria Pisana

研究点 (7)

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