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
- 否
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
研究点 (26)
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