Clinical trial NCT04727723: Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Keywords: GEP-NET
Gastro-Entero-Pancreatic
Neuroendocrine Tumour
AAA
Advanced Accelerator Applications
Luthatera
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study plans to enroll patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 48 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 48 months
measure: Duration of Response (DoR), for those patients who achieve a best response of PR or better
timeFrame: Up to 48 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 48 months
measure: Duration of Clinical Benefit, for those patients who achieve a best response of SD or better
timeFrame: Up to 48 months
measure: Time to Progression (TTP)
timeFrame: Up to 48 months
measure: Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-C30 questionnaire
timeFrame: Up to 48 months
measure: Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire
timeFrame: Up to 48 months
measure: Time to Deterioration (TTD) in global health scale (TTD- global health scale)
timeFrame: Baseline, up to 48 months
measure: Time to Deterioration (TTD) in diarrhoea item (TTD- diarrhoea item)
timeFrame: Baseline, up to 48 months
measure: Time to Deterioration (TTD) in fatigue item (TTD- fatigue item)
timeFrame: Baseline, up to 48 months
measure: Time to Deterioration (TTD) in pain item (TTD- pain item)
timeFrame: Baseline, up to 48 months
measure: Number of patients with Adverse Events (AEs) related to study drug
timeFrame: Up to 48 months
measure: Seriousness and relationship to Lutathera® treatment
timeFrame: Up to 48 months
measure: Incidence of deaths due to any cause.
timeFrame: Up to 48 months
measure: Number of participants with notable changes in laboratory parameters
timeFrame: Up to 48 months
measure: Number of participants with notable changes in physical examination
timeFrame: Up to 48 months
measure: Number of participants with notable changes in vital signs
timeFrame: Up to 48 months
measure: Number of participants with notable changes in electrocardiogram (ECG)
timeFrame: Up to 48 months
measure: Changes in Karnofsky Performance Status (KPS) scores
timeFrame: Up to 48 months
measure: Baseline characteristics of patients selected
timeFrame: Baseline
measure: Correlation of possible prognostic factors with clinical effectiveness outcomes.
timeFrame: Up to 48 months
measure: Describe radiation emission levels at one metre distance of patients treated
timeFrame: Up to 18 months
measure: Describe dosimetry data after administration (if dosimetry is performed)
timeFrame: Up to 18 months
measure: Number of days of hospitalization for Lutathera® treatment.
timeFrame: Up to 18 months
measure: Frequency of hospitalization.
timeFrame: Up to 48 months
measure: Duration of hospitalization
timeFrame: Up to 48 months
measure: Extent of usage of concomitant medications for AE treatment.
timeFrame: Up to 48 months
measure: Changes in use of concomitant medications for symptoms management
timeFrame: Up to 48 months
measure: Information about the patient's diagnosis-related group (DRG)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Cona
country: Italy
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
city: Latina
country: Italy
facility: Novartis Investigative Site
city: Meldola
country: Italy
facility: Novartis Investigative Site
city: Messina
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Negrar
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
city: Rionero In Volture
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Rozzano
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: