EUCTR2008-001755-22-BE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. - Engot-OV-1 MITO-8
ational Cancer Institute Naples, Italy0 个研究点目标入组 250 人开始时间: 2009年2月18日最近更新:
适应症
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 the end of the last cycle of a platinum based therapy
- •* Indication for chemotherapy, but no more than 2 previous lines of previous chemotherapy
- •* 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
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
- •* Previous treatment with stealth liposomal doxorubicin
- •* Residual peripheral neuropathy >= Grade 3
- •* 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 >= 1.25 x normal values) or liver function (ALT or AST >= 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
- •*Concomitant participation in any other trial of systemic therapy or previous participation within 30 days before randomization
- •*Refusal of informed consent
研究者
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