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临床试验/EUCTR2006-003332-29-GB
EUCTR2006-003332-29-GB进行中(未招募)1 期

A Randomised Phase II trial of Epirubicin, Oxaliplatin and Capecitebine (EOX) versus Docetaxel and Oxaliplatin (EITax) in the treatment of Advanced Gastro-oesophageal cancer - The ELECT trial - ELECT trial

ICORG, all-Ireland Cooperative Oncology Research Group0 个研究点目标入组 140 人开始时间: 2008年8月21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
140

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

  • Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning.
  • No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if >12 months previously.)
  • Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (>3 admissions for infective exacerbation in past 12 months) etc.
  • ECOG performance status = 2.
  • Age = to 18.
  • Life expectancy = 3 months
  • Adequate renal, hepatic and bone marrow function
  • Creatinine Clearance = 50 ml/min as calculated using the Cockcroft and Gault formula.
  • Liver function tests:
  • Bilirubin = 1.0 x ULN
  • AST = 1.5 x ULN
  • ALT = 1.5 x ULN
  • Haemoglobin > 10.0 g/dl
  • Absolute neutrophil count >1.5 x 10 to the power of 9 /L
  • Platelet count > 100 x 10 to the power of 9 /L
  • Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • 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

  • Symptoms or signs of peripheral neuropathy
  • Patients known to have second or third degree heart block.
  • Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
  • Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
  • Pregnant or nursing.
  • Female of child-bearing potential not taking adequate contraceptive precautions.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

研究者

发起方
ICORG, all-Ireland Cooperative Oncology Research Group

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