Clinical trial NCT04696042: Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs
Official title: Prospective Observational Study to Assess the Effectiveness and Safety of Lanreotide Autogel® in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Asia Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Keywords: Neuroendocrine tumor
Somatostatin analogue
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul St. Mary's Hospital
name: Severance Hospital
name: Seoul National University Bundang Hospital
First posted: 2021-01-06
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: G1-2 GEP-NET patients who would be treated with lanreotide will be included in this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival rate at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Response rates
timeFrame: 2 years
measure: Disease control rates
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Chromogranin A response
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Changhoon Yoo
Study officials:
affiliation: Asan Medical Center
name: Changhoon Yoo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gastrointestinal Pathology Study Group of Korean Society of Pathologists; Cho MY, Kim JM, Sohn JH, Kim MJ, Kim KM, Kim WH, Kim H, Kook MC, Park DY, Lee JH, Chang H, Jung ES, Kim HK, Jin SY, Choi JH, Gu MJ, Kim S, Kang MS, Cho CH, Park MI, Kang YK, Kim YW, Yoon SO, Bae HI, Joo M, Moon WS, Kang DY, Chang SJ. Current Trends of the Incidence and Pathological Diagnosis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Korea 2000-2009: Multicenter Study. Cancer Res Treat. 2012 Sep;44(3):157-65. doi: 10.4143/crt.2012.44.3.157. Epub 2012 Sep 30.
citation: Kim SJ, Kim JW, Oh DY, Han SW, Lee SH, Kim DW, Im SA, Kim TY, Heo DS, Bang YJ. Clinical course of neuroendocrine tumors with different origins (the pancreas, gastrointestinal tract, and lung). Am J Clin Oncol. 2012 Dec;35(6):549-56. doi: 10.1097/COC.0b013e31821dee0f.
citation: Pavel M, O'Toole D, Costa F, Capdevila J, Gross D, Kianmanesh R, Krenning E, Knigge U, Salazar R, Pape UF, Oberg K; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for the Management of Distant Metastatic Disease of Intestinal, Pancreatic, Bronchial Neuroendocrine Neoplasms (NEN) and NEN of Unknown Primary Site. Neuroendocrinology. 2016;103(2):172-85. doi: 10.1159/000443167. Epub 2016 Jan 5. No abstract available.
citation: Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.
citation: Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.