EUCTR2007-000618-35-DK进行中（未招募）不适用
PHASE II TRIAL OF PACLITAXEL, GEMCITABINE AND CISPLATIN IN PATIENTS WITH RELAPSING GERM CELL CANCER AFTER FIRST LINE CHEMOTHERAPY - relapse cis-tax-gem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- Male
入选标准
- •·Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
- •·Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
- •·Age greater than or equal to 18 years;
- •·Performance status 0,1,2 or 3
- •·WBC > 3x109/l, ANC > 1,5x109/l, platelet count > 100x109/l; serum bilirubin < 1.5 x the upper limit of normal;
- •·Adequate renal function (Glomerular Filtration Rate (GFR) >?60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
- •·signed informed consent;
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Uncontrolled active severe clinical infection (CTC grade 3 or 4).
- •·Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
- •·Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.
- •·Second malignancy other than basal or squamous cell skin cancer.
研究者
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