Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice. (PanNET)

June 9, 2021 updated by: Ipsen

Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice

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.

Study Overview

Status

Terminated

Conditions

Pancreatic Neuroendocrine Tumor

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Portugal
- - Coimbra, Portugal, 300-075
    - Ipo Coimbra
  - Lisboa, Portugal, 1099-023
    - Ipo Lisboa
  - Porto, Portugal, 4200-319
    - Hospital São João
Spain
- - Alicante, Spain, 03010
    - Hospital general de Alicante
  - Almería, Spain, 04009
    - Hospital Torrecardenas
  - Badajoz, Spain, 06010
    - Hospital Universitario de Badajoz
  - Badalona, Spain, 08916
    - ICO Badalona
  - Baracaldo, Spain, 48903
    - Hospital de Cruces
  - Barcelona, Spain
    - Hospital Santa Creu i Sant Pau
  - Barcelona, Spain, 08035
    - Hospital Universitario Vall Hebrón
  - Bilbao, Spain, 48013
    - Hospital Basurto
  - Burgos, Spain, 09006
    - Hospital Universitario de Burgos
  - Cadiz, Spain, 11510
    - Hospital Universitario Puerto Real
  - Ciudad Real, Spain, 13005
    - Hospital General Ciudad Real
  - Cáceres, Spain, 10003
    - Hospital San Pedro de Alcantara
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofia
  - Donostia, Spain, 20014
    - Hospital Donostia
  - Granada, Spain, 18014
    - Hospital Virgen de las Nieves
  - Hospitalet de Llobregat, Spain, 08908
    - ICO Bellvitge
  - Huelva, Spain, 21005
    - Hospital Juan Ramon Jimenez
  - Ibiza, Spain, 07800
    - Hospital Can Misses
  - Jerez De La Frontera, Spain, 11407
    - Hospital de Jerez
  - Las Palmas De Gran Canaria, Spain, 35010
    - Hospital U. de Gran Canaria Negrín
  - Murcia, Spain
    - Hospital Morales Meseguer
  - Murcia, Spain, 30120
    - Hospital Clínico U. Virgen de la Arrixaca
  - Málaga, Spain, 29010
    - Hospital Virgen de la Victoria
  - Ourense, Spain, 32005
    - Hospital Santa María Nai
  - Oviedo, Spain, 33011
    - Hospital Universitario Central de Asturias
  - Palma De Mallorca, Spain, 07120
    - Hospital Son Espases
  - Pamplona, Spain, 31008
    - Hospital de Navarra
  - Reus, Spain, 43204
    - Hospital Sant Joan de Reus
  - Sabadell, Spain
    - Corporacio Sanitaria Parc Tauli
  - Salamanca, Spain, 37007
    - Hospital Clínico de Salamanca
  - Santa Cruz De Tenerife, Spain, 38010
    - Hospital U. Nuestra Señora de Candelaria
  - Santander, Spain, 39008
    - Hospital Marqués de Valdecillas
  - Santiago De Compostela, Spain, 15706
    - Hospital Conxo
  - Segovia, Spain, 40002
    - Hospital General de Segovia
  - Sevilla, Spain, 41009
    - Hospital Virgen Macarena
  - Sevilla, Spain, 41013
    - Hs. Virgen del Rocio
  - Terrassa, Spain, 08221
    - Hospital Mutua Terrassa
  - Toledo, Spain, 45004
    - Hospital Virgen de la Salud Toledo
  - Valencia, Spain, 46014
    - Hospital General de Valencia
  - Valencia, Spain, 46014
    - Hospital Universitario Y Politecnico La Fe
  - Vigo, Spain, 36312
    - Hospital Alvaro Cunqueiro
  - Zaragoza, Spain, 50009
    - Hospital Miguel Servet
  - Zaragoza, Spain, 50009
    - Hospital Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) rate at 24 months Time Frame: 24 months	To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) rate at 12 months Time Frame: 12 months	PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment	12 months
Medical tumour-related intervention Time Frame: Baseline	Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study	Baseline
Time from diagnosis to first therapeutic intervention Time Frame: Baseline	Description of the disease history management of subjects with PanNET	Baseline
Quality of Life (QoL) Time Frame: From baseline up to 24 months	To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents "not at all" and 4 "very much".	From baseline up to 24 months
Median time to lanreotide discontinuation Time Frame: Up to 24 months		Up to 24 months
Changes of Chromogranin A (CgA) levels Time Frame: Every 6 months up to 24 months	Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit	Every 6 months up to 24 months
Changes of Glycated hemoglobin (HbA1c) levels Time Frame: Every 6 months up to 24 months	Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit	Every 6 months up to 24 months
Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels Time Frame: Every 6 months up to 24 months	Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit	Every 6 months up to 24 months
Changes of pro-Brain Natriuretic Peptide (proBNP) levels Time Frame: Every 6 months up to 24 months	Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit	Every 6 months up to 24 months
Patient satisfaction Time Frame: Baseline visit and 12 months	To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy).	Baseline visit and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2019

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria