EUCTR2015-004762-28-IT进行中（未招募）1 期
Multicentric prospective, randomized, clinical trial for the treatment of patient with relapsed Osteosarcoma (OS) - OsteoREC2015
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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)High grade relapsed OS
- •2)Relapsed disease within 24months form the inital diagnosis
- •3) Plural-lung relapse with more than 2 nodules
- •4) First releapsed disease (regardless the site) not amenable for surgery
- •5) Second relapse regardless the site and resecability
- •6) Age = 4 yrs
- •7)Lansky score o Karnofsky Performance status >60%
- •8) Notrmal for age kidney and liver functionality
- •9) LVEF > 50%.
- •10) WBC 3 x 109/L, plateelets >100 x 109/l.
- •11) Negative pregnancy test for female and effective contraception method for potentially feritile females
- •For fertile female patients is required a contraception methods needs to be taken for all the treatment period. Contraception method for male patients need to taken up to 6 month to the end of treatment
- •12) Provvision of written 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 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Clincal controindications to the use of IMPs.
- •2) Social, psycological and geographical condition that could comprimise/jeopadize the study.
- •3) Active HIV, HBV e HCV infection
- •4) Pregnancy or breast feeding
- •5) Previous treatment with Gem-Dox and/or HD-IFO).
研究者
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