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临床试验/EUCTR2007-000354-31-IT
EUCTR2007-000354-31-IT进行中(未招募)不适用

A randomized trial investigating the role of FOLFOX-4 regimen duration (3 versus 6 months) and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer - 3 months vs 6 months FOLFOX-4

GISCAD0 个研究点开始时间: 2007年11月22日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  •  Histologically confirmed AJCC/UICC high-risk stage II or stage III colon cancer .
  •  Age >18 years
  •  Curative surgery no less than 3 and no more than 8 weeks prior to randomization
  •  ECOG performance Status (ECOG-PS) <1
  •  Signed written informed consent obtained prior to any study specific procedures
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  •  Macroscopic or microscopic evidence of residual tumor
  •  Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer
  •  Other malignancies within the last 5 years
  •  Lactating women
  •  Fertile women not willing to use effective means of contraception
  •  History of clinically relevant psychiatric disability , precluding informed consent
  •  Clinically relevant cardiovascular disease
  •  Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study

研究者

发起方
GISCAD

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