NCT00127049Unknown2 期
A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Complete response rate
研究概览
简要总结
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients older than 16 years
- •Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
- •Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:
- •Testicular primary site
- •Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
- •Either a complete response or a partial response with normal serum AFP and HCG
- •Relapse documented by rising AFP and/or HCG or by a biopsy
- •No previous carcinoma, except basal-cell carcinoma of the skin
- •Adequate renal function: measured or calculated creatinine clearance> 60 ml/min
- •Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubin < 1.5 fold the upper normal value
- •Signed informed consent.
排除标准
- •Patients infected by the human immunodeficiency virus (HIV)
- •Patients who do not fit inclusion criteria
结局指标
主要结局
Complete response rate
次要结局
- Toxicity
- Progression free survival
- Overall survival
研究者
研究点 (2)
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