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临床试验/NCT00168870
NCT00168870Unknown2 期

Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2003年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
48
试验地点
2
主要终点
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

研究概览

简要总结

This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

详细描述

Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Metastatic ocular melanoma

排除标准

  • Prior treatment with chemotherapy
  • Active 2nd malignancy
  • Cerebral metastasis

结局指标

主要结局

Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

次要结局

  • Time to progression

研究者

申办方类型
Other

研究点 (2)

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