Clinical trial NCT03895463: Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice
Official title: Prospective Noninterventional Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Tumours (GEP-NETs) in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects with GEP-NETs eligible for treatment with Lanreotide Autogel 120 mg or currently being treated with Lanreotide Autogel 120 mg every 28 days for a period of up to 5 months. Subjects will receive treatment as prescribed by the physician and in accordance with the current Summary of Product Characteristics (SmPC).

Brief summary: The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.


Eligibility criteria: Inclusion Criteria:

* Functioning or non-functioning histopathologically confirmed, locally advanced or metastatic (grade 1 or grade 2 according to the World Health Organisation (WHO) 2017 classification and European Neuroendocrine Tumour Society (ENETS) grading system) GEP-NET G1,G2 (Ki67≤10%, based on recent Ki67).
* Measurable disease, as defined by RECIST 1.0, on a CT scan/MRI obtained up to 6 weeks prior to initiation of treatment with Lanreotide Autogel 120 mg.
* Subject eligible for treatment with Lanreotide Autogel 120 mg or subject currently being treated with Lanreotide Autogel 120 mg administered every 28 days for a period no longer than 5 months prior to inclusion
* Treatment with Lanreotide Autogel 120 mg alone, according to local Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Lanreotide Autogel treatment for more than 5 months prior to inclusion into the study
* Concomitant anti-proliferative medication/therapies for GEP NET at initiation of Lanreotide Autogel treatment (e.g. Peptide Receptor Radionuclide Therapy (PRRT), cytotoxic chemotherapy, targeted therapy everolimus, sunitinib, interferon, loperamide).
* Has been treated with PRRT, chemotherapy, everolimus, sunitinib or interferon within 3 months prior to initiation of Lanreotide Autogel treatment
* Parallel participation in an interventional study

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Median PFS
timeFrame: 24 months
measure: Tumour origin
timeFrame: 24 months
measure: Tumour grade
timeFrame: 24 months
measure: Quality of Life (QoL)
timeFrame: 24 months
measure: Disease Control Rate
timeFrame: 24 months
measure: Chromogranin A (CgA) level
timeFrame: 24 months
measure: Patients' satisfaction
timeFrame: 24 months
measure: Urine 5-hydroxyindoleaceticacid (5-HIAA) levels
timeFrame: 24 months
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
city: Kielce
country: Poland
facility: Świętokrzyskie Centrum Onkologii
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
city: Warsaw
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny
city: Wrocław
country: Poland
facility: Dolnośląskie Centrum Onkologii we Wrocławiu
city: Łódź
country: Poland
facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: