NCT00420563已完成2 期
A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Progression free survival rate at 2 months
研究概览
简要总结
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
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
- 否
入选标准
- •Age > or = 18
- •PS-WHO < or = 1
- •Histologically proven cancer
- •No other therapeutic proposal
- •Treatment can be orally taken
- •Radiologic proof of evolutive character of the disease
- •Effective contraception
排除标准
- •Hypercalcemia ( Ca > 2.65 mmol/l)
- •Breast cancer
- •Thrombosis or pulmonary embolism
- •Dysphagia, malabsorption
- •Polynuclear neutrophil leukocytes < 1000/mm3
- •Treatment with Tegretol
- •Active and uncontrolled infection
- •Evolutive psychiatric disease
- •Pregnant or lactating woman
研究组 & 干预措施
MEGESTROL
Active Comparator
干预措施: MEGESTROL (Drug)
CYCLOPHOSPHAMIDE
Experimental
干预措施: CYCLOPHOSPHAMIDE (Drug)
结局指标
主要结局
Progression free survival rate at 2 months
时间窗: 2 months
次要结局
- Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months(After 2, 4 and 6 months of treatment)
- Toxicity according to NCI scale v3.0(During study treatment)
- Biological markers(the 2 first months of treatment)
- Overall survival(Until death of the patient or until study analysis)
- Median time between the beginning of treatment and hospitalization due to progression or toxicity(time of the study)
研究者
研究点 (4)
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