SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 20
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.
详细描述
Patient data will be collected from medical records after obtaining consent and retrospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained prior to any data collection.
- •Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour
- •Aged ≥18 years.
排除标准
- 未提供
研究组 & 干预措施
Lutathera
干预措施: Lutetium [177Lu] oxodotreotide/dotatate (Device)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 12 months
Defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.
Overall survival (OS)
时间窗: Up to 12 months
Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Overall response rate (ORR)
时间窗: Up to 12 months
Is determined by imaging technique according to RECIST criteria v1.1 and is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1
次要结局
- Prognostic factors(Up to 12 months)
- Adverse Events (AEs)(Up to 12 months)
- Areas for improvement care(Up to 12 months)
- Characteristics of the population .(Up to 12 months)
- Health-related Quality of Life (HRQoL)(Up to 12 months)