EUCTR2004-002399-40-DK进行中（未招募）不适用
Carboplatin + paclitaxel vs carboplatin + stealth liposomal doxorubicin. A randomised multicentre trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
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
- Female
入选标准
- •Inclusion criteria
- •*Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
- •*Indication for chemotherapy treatment
- •*Age < 75 years.
- •*Life expectancy of at least 3 months
- •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
- •Exclusion criteria
- •*Previous or concomitant malignant neoplasia (not including basocellular or
- •spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided
- •they are being adequately treated).
- •*Performance Status (ECOG) _ 3.
- •*Previous chemotherapy treatment
- •*Heart disease (heart failure, myocardial heart attack during the 6 months prior to
- •the trial, atrioventricular block of any degree, serious arrhythmia)
- •*Leukocytes < 4000/mm3, neutrophils < 2000/mm3, platelets < 100000/mm3
- •*Modifications of renal function (Creatininaemia _ 1.25 times the upper normal
- •limit) or liver function (SGOT or SGPT _ 1.25 times the upper normal limit)
- •*Present or suspected haemorrhagic syndromes
- •*Uncooperative and/or unreliable patients
- •*Patients' inability to access the centre due to area of residence
- •*Refusal of informed consent
研究者
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