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临床试验/EUCTR2016-000767-17-IT
EUCTR2016-000767-17-IT进行中(未招募)1 期

A randomized phase II trial of captem or folfiri as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET imaging and biological markers (SENECA study) - SENECA

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 112 人开始时间: 2018年9月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
112

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Histopathologic diagnosis of neuroendocrine carcinomas (GEP NEC and lung NEC), G3 with ki67 > 20%.
  • 2.Male or Female, aged >=18 years.
  • 3.Measurable disease according to RECIST 1.1 criteria.
  • 4.Patients already received a first line treatment for metastatic disease with platinum compound–based regimen chemotherapy (Cisplatin/Carboplatin and etoposide; folfox4 or capox).
  • 5.Life expectancy greater than 3 months
  • 6.ECOG performance status = 2
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 1
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 42
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • 1.Ki67< 20%.
  • 2.Patients with metastatic NECs already treated with irinotecan regimen.
  • 3.Patients with a known hypersensitivity to fluorouracil or calcio levofolinato or Irinotecan or their recipients.
  • 4.All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE).
  • 5.Life expectancy minor than 3 months.
  • 6.ECOG performance status >2.

研究者

发起方
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

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