EUCTR2009-009882-33-GB进行中（未招募）1 期
A multi-centre phase II study using Carboplatin AUC-10 for metastatic seminoma with IGCCCG good prognosis disease - therapy directed by initial metabolic response on PET-CT [CAR-PET] - CAR-PET
St Bartholomew's and The London NHS Trust0 个研究点目标入组 48 人开始时间: 2010年6月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
入选标准
- •Inclusion criteria
- •1.Metastatic seminoma-IGCCCG good prognosis.
- •2.Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance in adequate timeframe)
- •3.ECOG Performance status 0-3
- •4.Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable)
- •5.Males aged =18 and =75 years
- •6.Able to give written informed consent prior to study entry
- •7.Patients must be sterile or agree to use adequate contraception during the period of therapy
- •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
- •Exclusion Criteria:
- •1.Metastatic seminoma with any non-pulmonary visceral metastases
- •2.Raised Alpha-fetoprotein
- •3.Any previous chemotherapy or radiotherapy
- •4.Currently enrolled in any other investigational drug study
- •5.Other malignancy except basal cell
研究者
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