Status:
COMPLETED
Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Seoul St. Mary's Hospital
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
19+ years
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04696042
Start Date
January 1 2021
End Date
January 27 2025
Last Update
January 28 2025
Active Locations (1)
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1
Changhoon Yoo
Seoul, Seoul, South Korea, 138-736