NCT00568464终止2 期
Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.
详细描述
80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 10-65 years old
- •Histological confirmed ESFT
- •No previous therapy
- •ECOG performance status less than 2
- •Life expectancy of more than 12 weeks
- •Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet > 80×109/L, Hb > 80×1012/L, serum creatine < 1×upper limitation of normal(ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN
排除标准
- •Pregnant or lactating women
- •Received treatment for the disease previously
- •Serious uncontrolled diseases and intercurrent infection
- •The evidence of CNS metastasis and bone marrow involvement
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •History of allergy to the drugs in this trial
- •Abnormal LVEF level
研究组 & 干预措施
A
Experimental
干预措施: VCR, CTX, ADM; IFO, VP-16 (Drug)
结局指标
主要结局
Response Rate
时间窗: every two cycles
次要结局
- Toxicity(every cycle)
研究者
研究点 (1)
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