EUCTR2005-001072-13-DK进行中（未招募）1 期
A risk-adapted strategy of the use of dose-dense chemotherapy in patient with poor-prognosis dissemined non-seminomatous germ cell tumors. GETUG 13 / 0206
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- FNCLCC
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1-Patients older than 16 years.
- •2-Evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are elevated)
- •3-Testicular, retroperitoneal, or mediastinal primary site.
- •4-Evidence of disseminated disease (clinical stages II or III).
- •5-Disease classified as poor prognosis according to IGCCCG criteria:
- •- Primary mediastinal NSGCT (any stage) or
- •- Non-pulmonary visceral metastases or
- •- HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.
- •6-No prior chemotherapy.
- •7-No previous malignancy, except for basal-cell carcinoma of the skin.
- •8-Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance> 60 ml/min.
- •Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)]
- •(for females, multiply by 0.85)
- •9-Absolute granulocyte count >or= 1,500/mm3, platelets > or = 100,000 mm3, bilirubine < or = 1.5x the upper limit of normal value.
- •10-Signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1-Patients infected by the Human Immunodeficiency Virus (HIV).
- •2-Patients who do not fit inclusion
- •3-Female patients.
研究者
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