Metastatic or Refractory Soft Tissue Sarcomas and Metronomic Cyclophosphamide: Further Assessment of Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data.
Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients.
The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18
- •with inoperable or metastatic Soft Tissue Sarcoma
- •treated with Metronomic Cyclophosphamide
- •in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté)
- •between January 2005 and December 2021
排除标准
- •patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-Free Survival is defined as the period from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause Assessment period was from the day of the first day of MCP administration until the first observation of progression or death from any cause. Disease progression is defined according to RECIST Ver. 1.1.
次要结局
- Control Rate(From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Progression Rate(3 and 6 Months)
- Response Rate (RR)(From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Overall Survival(From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months)