EUCTR2008-001755-22-IT进行中（未招募）不适用
STEALTH LIPOSOMAL DOXORUBICIN vs CARBOPLATIN/PACLITAXEL IN PATIENTS WITH OVARIAN CANCER RECURRENCE BETWEEN SIX AND TWELVE MONTHS AFTER PREVIOUS PLATINUM BASED CHEMOTHERAPY: PHASE III MULTICENTER RANDOMIZED STUDY - MITO-8
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点目标入组 250 人开始时间: 2009年2月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Histological or cytological diagnosis of ovarian cancer
- •Disease recurrence between 6 and 12 months after a first-line platinum based therapy
- •Indication for chemotherapy, but no more than 2 previous lines of previous therapy
- •Life expectancy of more than 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
- •Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
- •ECOG Performance Status ³ 3
- •Previous treatment with stealth liposomal doxorubicin
- •Residual peripheral neuropathy > Grade 2
- •Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
- •Neutrophils < 2000 x mm3, platelets < 100000 x mm3
- •Inadequate renal function (creatinine ³ 1.25 x normal values) or liver function (ALT or AST ³ 1.25 x normal values)
- •Present or suspected hemorrhagic syndromes
- •Inability to comply with protocol and follow-up
- •Inability to access study site for clinical visits
- •Refusal of informed consent
研究者
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