NCT00204633已完成2 期
Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- frequency of transfusions (reduction from 90% to 65%)
研究概览
简要总结
The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Poor prognosis" according IGCCCG-criteria:
- •Primary mediastinal tumor
- •Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
- •Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10 x upper normal limit
- •No previous chemotherapy
- •Age > 18 years
- •Performance-Status: WHO =< 2
- •Written informed consent
- •Ability to give informed consent
排除标准
- •Hemolysis
- •Hematological disease with insufficient erythropoiesis
- •Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
- •Uncontrolled arterial hypertension
- •Treatment with rh-Erythropoetin during trial
- •Creatinin clearance < 50 ml/min
- •Insufficient bone marrow function (WBC count < 3.000/ml or platelets < 100.000/µl)
- •Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
- •Second malignancy, except of completely resected basal cell carcinoma of the skin
结局指标
主要结局
frequency of transfusions (reduction from 90% to 65%)
次要结局
- proportion of patients with no transfusions
- developing of hemoglobin levels
- objective remission rate
- progression-free- and overall-survival (pfs, os)
- quality of life
研究者
研究点 (2)
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