Neuroendocrine Tumors
Conditions
Keywords
Neuroendocrine tumor, Somatostatin analogue
Brief summary
Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial. According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.
Interventions
Lanreotide autogel 90-120 mcg, every 4 weeks
Sponsors
Samsung Medical Center
Seoul St. Mary's Hospital
Severance Hospital
Seoul National University Bundang Hospital
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Male or female subject aged ≥18 years and legally capable to provide informed consent * Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET * Well differentiated tumor * Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria * Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study * Use of Lanreotide autogel® monotherapy by local label (SmPC). * Concomitant locoregional therapy such as surgery, RFA or TAE is allowed.
Exclusion criteria
* Parallel participation in an interventional study * Lanreotide treatment for more than 5 months prior inclusion into the study * Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR). * Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate at 2 years | 2 years | Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | Time between lanreotide treatment initiation and disease progression or death |
| Response rates | 2 years | Proportion of patients with tumor response by RECIST version 1.1 |
| Disease control rates | 2 years | Proportion of patients with tumor response and stable disease by RECIST version 1.1 |
| Overall survival | 2 years | Time between lanreotide treatment initiation and death due to any cause |
| Chromogranin A response | 2 years | Change of serum chromogranin A levels during lanreotide treatment |
Countries
South Korea
Outcome results
None listed