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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 164
- Locations
- 18
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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).
Intervention: Lutathera® (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: 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.
Secondary Outcomes
- 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)