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临床试验/NCT00226473
NCT00226473Unknown4 期

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

Dermatologic Cooperative Oncology Group26 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年9月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
26
主要终点
Overall survival

研究概览

简要总结

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

研究设计

研究类型
Interventional
分配方式
Non 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histological diagnosis of metastatic melanoma (stage IV)
  • progressive disease after first-line chemotherapy or immuno-chemotherapy
  • Karnofsky-index > 60%
  • informed consent

排除标准

  • Uvea melanoma
  • another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
  • severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

结局指标

主要结局

Overall survival

次要结局

  • Quality of life analysis
  • Objective tumor response rate in study arm B
  • Time to tumor progression
  • Cost analysis

研究者

发起方
Dermatologic Cooperative Oncology Group
申办方类型
Other

研究点 (26)

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