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

Study Type

Observational

Enrollment (Actual)

54

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

      • Coimbra, Portugal, 300-075
        • IPO Coimbra
      • Lisboa, Portugal, 1099-023
        • IPO Lisboa
      • Porto, Portugal, 4200-319
        • Hospital Sao Joao
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Almería, Spain, 04009
        • Hospital Torrecárdenas
      • 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 Hebron
      • 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 Alcántara
      • 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 Ramón Jiménez
      • 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 Maria 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 Politécnico 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

No

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

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

May 10, 2019

First Posted (ACTUAL)

May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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