EUCTR2012-001010-42-IT进行中（未招募）不适用
A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma - ISG Os Rec
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.patients with high-grade malignant relapsed osteosarcoma 2.age at diagnosis <50 years 3.Lansky score o Karnofsky Performance status > 60% 4.First or subsequent relapse of osteosarcoma surgically unresectable or for whom surgery was oncologically not appropriate 5.Good organ function defined by: 1) serum creatinine < 2 times the upper limit for age, 2) total bilirubin <1.5 times the upper limit of age, 3) transaminases = 2.5 times the upper limit for age, 4) alkaline phosphatase = 5 times the upper limit for age (with the exclusion of patients with skeletal metastases) 6.Normal Heart function (VEF > 50%) 7.White blood cells >3 x 109/l and platelets >100 x 109/l 8.For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study 9.Written signed informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Medical contraindications to the use of the drugs included in the Protocol. 2.Psychological conditions that don’t ensure either a good adhesion to the Protocol or a proper management of toxicity or a proper understanding of the study 3.Either HBV or HCV or HIV active infection 4.Previouly treatment with either Cyclophosphamide+ Etoposide or high dose Ifosfamide Pregnant or lactating patients
研究者
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