A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
研究概览
简要总结
Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced gastro-oesophageal cancer, their role, however, in the management of this disease remains unclear. Furthermore it is unclear whether this disease is optimally treated with a combination of two or three cytotoxic drugs. This trial aims to determine whether the combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the comparator arm for this evaluation.
Primary Objective:
Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer.
Secondary Objective:
To examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.
详细描述
This is a randomised two-arm parallel group phase II study. 140 patients will be recruited over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and Oxaliplatin (EITax).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
- •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 ≤
- •Life expectancy ≥ 3 months
- •Adequate renal, hepatic and bone marrow function
- •Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).
- •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 109 /L, Platelet count > 100 x109/L.
- •Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
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, or male partner of 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
研究组 & 干预措施
Epirubicin, Oxaliplatin, Capecitabine
- Epirubicin 50mg/m2 (day 1) bolus injection
- Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours
- Capecitabine 625mg/m2 (days 1-21) b.d. orally
- 8 x 3-weekly cycle
干预措施: Epirubicin (Drug)
Epirubicin, Oxaliplatin, Capecitabine
- Epirubicin 50mg/m2 (day 1) bolus injection
- Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours
- Capecitabine 625mg/m2 (days 1-21) b.d. orally
- 8 x 3-weekly cycle
干预措施: Oxaliplatin (Drug)
Epirubicin, Oxaliplatin, Capecitabine
- Epirubicin 50mg/m2 (day 1) bolus injection
- Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours
- Capecitabine 625mg/m2 (days 1-21) b.d. orally
- 8 x 3-weekly cycle
干预措施: Capecitabine (Drug)
Docetaxel, Oxaliplatin
- Docetaxel 20mg/m2 (days 1, 8 & 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel)
- Oxaliplatin 85mg/m2 (days 1 & 15)in 250mls of 5% dextrose. i.v. over 2 hours
- 6 x 4-weekly cycle
干预措施: Oxaliplatin (Drug)
Docetaxel, Oxaliplatin
- Docetaxel 20mg/m2 (days 1, 8 & 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel)
- Oxaliplatin 85mg/m2 (days 1 & 15)in 250mls of 5% dextrose. i.v. over 2 hours
- 6 x 4-weekly cycle
干预措施: Docetaxel (Drug)
结局指标
主要结局
Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
时间窗: Two Years
次要结局
- To examine the effect of treatment on Quality of life.(2 years)
- In addition we will examine the effect of treatment on time to progression.(Two Years)
- To examine the effect of treatment on survival(2 years)
- To examine the associated toxicity from treatment(2 years)