Clinical trial NCT03947762: Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.
Official title: Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Neuroendocrine Tumor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients

Brief summary: The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.


Eligibility criteria: Inclusion Criteria:

* Subjects aged ≥ 18
* Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
* Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
* Subject with Eastern Cooperative Oncology Group (ECOG) ≤2

Exclusion Criteria:

* Subject who is participating in an interventional study
* Pregnant or breast-feeding women
* Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours

Primary outcomes:
measure: Progression-free survival (PFS) rate at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival (PFS) rate at 12 months
timeFrame: 12 months
measure: Medical tumour-related intervention
timeFrame: Baseline
measure: Time from diagnosis to first therapeutic intervention
timeFrame: Baseline
measure: Quality of Life (QoL)
timeFrame: From baseline up to 24 months
measure: Median time to lanreotide discontinuation
timeFrame: Up to 24 months
measure: Changes of Chromogranin A (CgA) levels
timeFrame: Every 6 months up to 24 months
measure: Changes of Glycated hemoglobin (HbA1c) levels
timeFrame: Every 6 months up to 24 months
measure: Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels
timeFrame: Every 6 months up to 24 months
measure: Changes of pro-Brain Natriuretic Peptide (proBNP) levels
timeFrame: Every 6 months up to 24 months
measure: Patient satisfaction
timeFrame: Baseline visit and 12 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: IPO Coimbra
city: Lisboa
country: Portugal
facility: IPO Lisboa
city: Porto
country: Portugal
facility: Hospital São João
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Almería
country: Spain
facility: Hospital Torrecardenas
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Badalona
country: Spain
facility: ICO Badalona
city: Baracaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Hebrón
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Bilbao
country: Spain
facility: Hospital Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real
city: Ciudad Real
country: Spain
facility: Hospital General Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Donostia
country: Spain
facility: Hospital Donostia
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Hospitalet de Llobregat
country: Spain
facility: ICO Bellvitge
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jimenez
city: Ibiza
country: Spain
facility: Hospital Can Misses
city: Jerez De La Frontera
country: Spain
facility: Hospital de Jerez
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital U. de Gran Canaria Negrín
city: Murcia
country: Spain
facility: Hospital Clínico U. Virgen de la Arrixaca
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Virgen de La Victoria
city: Ourense
country: Spain
facility: Hospital Santa María Nai
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital U. Nuestra Señora de Candelaria
city: Santander
country: Spain
facility: Hospital Marqués de Valdecillas
city: Santiago De Compostela
country: Spain
facility: Hospital Conxo
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hs. Virgen del Rocio
city: Terrassa
country: Spain
facility: Hospital Mutua Terrassa
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud Toledo
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: