ISRCTN08648791已完成3 期
A randomised phase III toxicity study of day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin for patients with International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis germ cell tumours, TE3
Barts and The London NHS Trust (UK)0 个研究点目标入组 212 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28327896 [added 07/03/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Patients aged 16 - 50 inclusive
- •2. Patients with proven good risk metastatic germ cell cancer of the testis
- •3. Patients eligible for treatment with bleomycin, etoposide and cisplatin
- •4. Patients who are able to understand their participation in the study and give written consent
排除标准
- •1. Patients who have had previous radiotherapy and/or chemotherapy
- •2. Patients with creatinine clearance less than 60 ml/min
- •3. Patients with a previous or concurrent second malignancy, except for basal cell skin cancer
- •4. Patients with any other major systemic illness
- •5. Impaired respiratory function i.e. shortness of breath on minimal exertion or hypoxia at rest, transfer coefficient for carbon monoxide (KCO), total lung capacity (TLC), forced expiratory volume in one second (FEV1) less than or equal to 60% predicted
研究者
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