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临床试验/EUCTR2010-018363-42-IT
EUCTR2010-018363-42-IT进行中(未招募)不适用

A phase II dose finding study of induction cisplatin, docetaxel and escalating doses of capecitabine followed by concurrent cetuximab and radiotherapy in locally advanced inoperable head and neck squamous cell carcinoma - DOXERT 1

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2010年12月27日最近更新:
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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

  • 1.Hystologically or cytologically confirmed HNC with exclusion of the nasopharynx 2.Locally advanced inoperable disease 3.age > 18 years 4.ECOG PS: 0-1 5.Life expectancy at least 3 months at study entrance 6.Normal bone marrow reserve (absolute neuthrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin > 9 g/dl) 7.Normal hepatic function (total serum bilirubin < 1.5 x upper limit of normal; liver transaminases > 3 x upper limit of normal) 8.Normal renal function (serum creatinine < 1,25 x upper limit of normal and creatinine clearance > 60 ml/min). 9.Normal cardiac function (assessed by ECG and ecocardiography with ejection fraction > 50%) 10.No pregnancy 11.No prior chemo or radiotherapy 12.Written informed consent.
  • 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

  • 1.Concomitant treatment with investigation agents 2.Nasopharygeal carcinoma 3.Brain metastases (CT scan or MRI required only in case of clinical suspicion of CNS metastases) 4.Second malignancies 5.History of myocardial infarction within the last 12 months

研究者

发起方
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

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