EUCTR2004-002113-36-SK进行中（未招募）1 期
Randomised trial of single agent doxorubicin versus doxorubicin plus ifosfamide in the first line treatment of advanced or metastatic soft tissue sarcoma
European Organisation for the Research and Treatment of Cancer0 个研究点目标入组 450 人开始时间: 2006年6月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- All
入选标准
- •-histological evidence of soft tissue sarcoma with advanced unresectable or metastatic disease
- •-histological evidence of high-grade soft tissue sarcoma (grade 2-3) according to the FNLCC grading system
- •-measurable lesion
- •-WHO performance status 0 or 1
- •- ANC>= 2X10e9/l and platelets >=100x10e9/l
- •Serum creatinine 120 mol/l or calculated clearance (Cockroft and Gault method) > 65 ml/min, two functioning kidneys
- •Bilirubin 30 mol/l, Albumin > 25 g/l.
- •-age between 18 and 60 years
- •-written informed consent
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-prior radiotherapy to the soleindex lesion available
- •-prior chemotherapy for advanced or metastatic disease
- •-other severe medical illness
- •- mixed mesodermal tumour
- •- Chondrosarcoma
- •- malignant mesothelioma
- •- neuroblastoma
- •- osteosarcoma
- •- Ewing's sarcoma / primitive neuroectodermal tumour
- •- desmoplastic small round cell tumour
- •- embryonal rhabdomyosarcoma
- •- alveolar soft part sarcoma
- •-symptomatic or known CNS metasases
- •-prior or concurent second primary malignant tumors
研究者
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