EUCTR2006-001375-38-AT进行中（未招募）不适用
Temozolomide and pegylated (PEG)-liposomal Doxorubicin in first line treatment of patients with Glioblastoma WHO Grad IV
Klinik und Poliklinik für Neurologie der Universität Regensburg am Bezirksklinikum0 个研究点目标入组 50 人开始时间: 2006年7月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Histopathologically confirmed glioblastoma multiforme (GBM, WHO grade IV)
- •Age: >= 18 and <= 70 years.
- •Karnofsky performance status >= 70%
- •Stable, non-increasing dose of corticosteroids 2 weeks before randomization
- •Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to randomization):
- •WBC >= 3000/microliter, Hb >= 10 g/dl
- •Platelets >= 100000/microliter;
- •Serum creatinine < 1.5 times upper limit of laboratory normal;
- •Total serum bilirubin < 1.5 times upper limit of laboratory normal;
- •ASAT and ALAT < 2,5 times upper limit of laboratory normal;
- •Alkaline phosphatase of < 2,5 times upper limit of laboratory normal.
- •Absence of known HIV infection, chronic hepatitis B or hepatitis C infection;
- •Absence of any other serious medical condition according to the medical judgement of the physician prior to randomization.
- •Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer.
- •Presence of medically approved contraception in any fertile (M/F) patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •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
- •prior chemotherapy
- •prior radiotherapy to the brain
- •Karnofsky performance index < 70%
研究者
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