NCT00189683Unknown3 期
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
Association Européenne de Recherche en Oncologie1 个研究点 分布在 1 个国家开始时间: 2005年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 1
研究概览
简要总结
To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.
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
- •Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
- •The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
- •Age>18 years
- •ECOG status 0 to 2
- •Biological criteria prior to any chemotherapy:
- •Neutrophils>1.5 109 g/l, platelets>100 109/l, haemoglobin>10 g/dl, Creatininaemia<150 mol/l, bilirubinaemia<2x normal level
- •Signed informed consent
- •Life expectancy > 3 months
排除标准
- •Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
- •Tumour progression after first line chemotherapy or before randomization
- •Other tumour pathology
- •Symptomatic cerebral metastases
- •Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency)
- •Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
- •Severe renal impairment (creatinine clearance < 30 ml/min)
- •Severe psychiatric disorder (other than controlled depressive syndrome)
- •Patient participating in another experiment
- •Pregnant women
研究者
研究点 (1)
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