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临床试验/EUCTR2008-001755-22-DE
EUCTR2008-001755-22-DE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 studyAmendment 2 title: a phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval in patients with ovarian cancer recurring between 6 and 12 months after previous platinum based chemotherapy - Engot-OV-1 MITO-8-Ovar 2.16

Philipps-University Marburg0 个研究点目标入组 250 人开始时间: 2010年7月9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
  • Indication for chemotherapy, but no more than 2 previous lines of previous therapy
  • Life expectancy of more than 3 months
  • Age 18 years or older
  • 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
  • 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 ? 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
  • Refusal of informed consent
  • Concomitant participation in any other trial of systemic therapy or previous
  • participation no longer than 30 days ago

研究者

发起方
Philipps-University Marburg

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