NCT00410462Unknown2 期
Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2006年10月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Six-month progression-free survival, in terms of complete response, partial response, or no change
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the activity and safety of brostallicin vs doxorubicin hydrochloride as first-line therapy in patients with relapsed, refractory, or metastatic soft tissue sarcoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
- Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Six-month progression-free survival, in terms of complete response, partial response, or no change
次要结局
- Objective tumor response
- Duration of response
- Overall progression-free survival
- Overall survival
- Safety (CTCAE v 3.0)
研究者
研究点 (2)
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