Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera (177Lu) Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic, Progressive, Well Differentiated (G1 and G2), Somatostatin Receptor Positive Gastroenteropancreatic-neuroendocrine Tumours (GEP-NETs) - REAL-LU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 18
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs who have been prescribed Lutathera® in standard clinical practice.
详细描述
Data on patients will be collected from the date when patient consent was obtained, during treatment with Lutathera® and for a follow-up period until end of study (EOS), defined as the time when the last enrolled patient has completed 36 months of assessments (unless early termination) after enrolment. Data will be collected in accordance with routine clinical visits.
The study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET).
- •Aged ≥18 years.
- •Patients must be naïve to treatment with Lutathera® at enrolment.
排除标准
- •Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.
研究组 & 干预措施
Lutathera®
Lutathera® will be administered according to the local label and according to the recommended treatment regimen in adults consisting of four equally divided doses of Lutathera® for a total of 29.6 GBq (800 mCi).
干预措施: Lutathera® (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 48 months
PFS, 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.
次要结局
- Seriousness and relationship to Lutathera® treatment(Up to 48 months)
- Incidence of deaths due to any cause.(Up to 48 months)
- Correlation of possible prognostic factors with clinical effectiveness outcomes.(Up to 48 months)
- Describe radiation emission levels at one metre distance of patients treated(Up to 18 months)
- Duration of hospitalization(Up to 48 months)
- Changes in Karnofsky Performance Status (KPS) scores(Up to 48 months)
- Baseline characteristics of patients selected(Baseline)
- Time to Progression (TTP)(Up to 48 months)
- Objective Response Rate (ORR)(Up to 48 months)
- Duration of Response (DoR), for those patients who achieve a best response of PR or better(Up to 48 months)
- Clinical Benefit Rate (CBR)(Up to 48 months)
- Duration of Clinical Benefit, for those patients who achieve a best response of SD or better(Up to 48 months)
- Time to Deterioration (TTD) in global health scale (TTD- global health scale)(Baseline, up to 48 months)
- Time to Deterioration (TTD) in diarrhoea item (TTD- diarrhoea item)(Baseline, up to 48 months)
- Time to Deterioration (TTD) in fatigue item (TTD- fatigue item)(Baseline, up to 48 months)
- Time to Deterioration (TTD) in pain item (TTD- pain item)(Baseline, up to 48 months)
- Number of patients with Adverse Events (AEs) related to study drug(Up to 48 months)
- Number of participants with notable changes in laboratory parameters(Up to 48 months)
- Number of participants with notable changes in physical examination(Up to 48 months)
- Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-C30 questionnaire(Up to 48 months)
- Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire(Up to 48 months)
- Number of participants with notable changes in vital signs(Up to 48 months)
- Number of participants with notable changes in electrocardiogram (ECG)(Up to 48 months)
- Frequency of hospitalization.(Up to 48 months)
- Extent of usage of concomitant medications for AE treatment.(Up to 48 months)
- Information about the patient's diagnosis-related group (DRG)(Up to 18 months)
- Describe dosimetry data after administration (if dosimetry is performed)(Up to 18 months)
- Number of days of hospitalization for Lutathera® treatment.(Up to 18 months)
- Changes in use of concomitant medications for symptoms management(Up to 48 months)