EUCTR2008-000551-10-BE进行中（未招募）1 期
Randomised Phase II study of biweekly versus fractionated triweekly combination Taxotere-Cisplatin-5FU in advanced gastric and gastro-esophageal junction cancer - DoGE01
Institut Jules Bordet0 个研究点目标入组 134 人开始时间: 2008年3月12日最近更新:
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
- 134
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
- •*Histologically proven chemotherapy-naïve advanced adenocarcinoma of the stomach, esogastric junction, or esophagus.
- •*Patients with locally advanced inoperable tumors rendered operable by chemotherapy, could be operated on.
- •*evaluable lesions
- •*A previous adjuvant chemotherapy for gastric cancer is authorized if the tumor has not progressed during or 6 months after chemotherapy administration, provided it contains no cisplatin.
- •*Age = 18 years
- •*Performance status < 2
- •*Hematological examination : Neutrophilic count = 1.5 X 106 / l, Platelets = 100 X 106 / l , Hemoglobin = 11 g / dl
- •*ASAT/ALAT = 1,5 X ULN , Alkaline Phosphatases < 2,5 ULN
- •*Bilirubin = 1 X ULN
- •*Written informed consent
- •*Clearance creatinine = 60 ml/min (calculated or evaluated by isotopic method)
- •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
- •*Unwillingness to take anticonceptional means for women in procreating age
- •*Ongoing pregnancy or lactation.
- •*Uncontrolled Central nervous system metastasis.
- •*History of another concomitant malignant disease with the exception of in situ cervix carcinoma or non-melanoma skin cancer
- •*Participation to another clinical study within 4 weeks before inclusion in this study
- •*Concomitant antineoplasic treatment.
- •*Previous use in adjuvant setting of more than 400 mg/m² (total cumulated dose) cisplatin
- •*Known deficiency in DPD or allergy to one or more drugs of the study
- •*History of other uncontrolled life-threatening or severe disease
- •*Uncontrolled infectious disease.
- •*Impossibility to assure an adequate follow-up due to psychological, familial, social and/or geographic reasons.
- •*Liver tests: Bilirubin > 1 x upper limit of normal (ULN), SASAT and/or SALAT >1.5 x ULN concomitant with alkaline Phosphatases > 2.5 x ULN.
- •*Clearance creatinine < 60 ml/min
- •*Uncontrolled angina pectoris or myocardial infarction < 6 weeks before beginning of the chemotherapy
研究者
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