A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- toxicity according to CTCAE v.5.0
研究概览
简要总结
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of high risk relapsed/ refractory osteosarcoma
- •Aged <= 40 years at the beginning of treatment
- •at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
- •disease evaluation according to RECIST criteria v.1.1
排除标准
- 未提供
结局指标
主要结局
toxicity according to CTCAE v.5.0
时间窗: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Disease evaluation
Progression Free Survival
时间窗: Evaluated during the first 4 months at the end of treatment
Disease remission or disease progression
growth modulation index - GMI
时间窗: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1)
次要结局
未报告次要终点
研究者
Prof. Franca Fagioli
Principal Investigator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna