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临床试验/EUCTR2009-017943-32-BE
EUCTR2009-017943-32-BE进行中(未招募)不适用

Study of the combination of gemcitabine, cetuximab and radiotherapy in patients with head and neck cancer - RAGE

Antwerp University Hospital0 个研究点目标入组 25 人开始时间: 2010年3月1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)
入组人数
25

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

  • Written and signed informed consent
  • Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation
  • Life expectancy of at least 12 weeks
  • Age > 18 years
  • Performance status of 0 or 1 according to the World Health Organization (WHO)
  • Adequate hematologic, cardiac, pulmonary, renal and liver function
  • 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

  • Pregnant or lactating women or women of childbearing potential without adequate contraceptive measures.
  • Known brain or leptomeningeal metastasis
  • Other serious medical conditions
  • Congestive heart failure, uncontrolled angina pectoris, uncontrolled hypertension or uncontrolled arrhythmia
  • Active infection
  • History of significant neurologic or psychiatric disorders
  • Known hypersensitivity reactions to cetuximab or gemcitabine or one of the excipients.
  • Altered fractionation radiotherapy.
  • Prior radiotherapy and/or chemotherapy (except as induction chemotherapy) within 6 months before enrolment

研究者

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