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
概览
- 阶段
- 2 期
- 干预措施
- CYCLOPHOSPHAMIDE
- 疾病 / 适应症
- Cancer
- 发起方
- Centre Oscar Lambret
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Progression free survival rate at 2 months
- 状态
- 已完成
- 最后更新
- 上个月
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.
研究者
入排标准
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
CYCLOPHOSPHAMIDE
干预措施: CYCLOPHOSPHAMIDE
MEGESTROL
干预措施: MEGESTROL
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)
研究点 (4)
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