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
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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 trialAdvanced Gastro-oesophageal cancerMedDRA version: 9.1Level: LLTClassification code 10062878Term: Gastrooesophageal cancerEUCTR2006-003332-29-IEICORG, all-Ireland Cooperative Oncology Research Group140
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