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临床试验/NCT00453232
NCT00453232已完成2 期

Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor

Cambridge University Hospitals NHS Foundation Trust14 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年8月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
14
主要终点
Toxicity

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.

详细描述

OBJECTIVES:

Primary

  • Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
  • Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the progression-free survival of patients treated with this regimen.

研究设计

研究类型
Interventional
分配方式
Non Randomized
主要目的
Treatment

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Toxicity

Feasibility

次要结局

  • Response rate
  • Progression-free survival

研究者

研究点 (14)

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