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Pancreatic Neuroendocrine TumorPanNETNCT03947762

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

An observational study of Pancreatic Neuroendocrine Tumor, run by Ipsen at 46 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neuroendocrine Tumor
How many people
54 participants
Where
46 sitesin 2 countries
Study dates
3 Jul 2019to 30 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospital patients

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

Spain43 sites

  • Hospital General de Alicante

    Alicante, 03010

  • Hospital Torrecardenas

    Almería, 04009

  • Hospital Universitario de Badajoz

    Badajoz, 06010

  • ICO Badalona

    Badalona, 08916

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital Universitario Vall Hebrón

    Barcelona, 08035

  • Hospital Santa Creu I Sant Pau

    Barcelona

  • Hospital Basurto

    Bilbao, 48013

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario Puerto Real

    Cadiz, 11510

  • Hospital General Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Juan Ramón Jimenez

    Huelva, 21005

  • Hospital Can Misses

    Ibiza Town, 07800

  • Hospital de Jerez

    Jerez de la Frontera, 11407

  • ICO Bellvitge

    L'Hospitalet de Llobregat, 08908

  • Hospital U. de Gran Canaria Negrín

    Las Palmas de Gran Canaria, 35010

  • Hospital Virgen de La Victoria

    Málaga, 29010

  • Hospital Clínico U. Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Morales Meseguer

    Murcia

  • Hospital Santa María Nai

    Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • Hospital de Navarra

    Pamplona, 31008

  • Hospital Sant Joan de Reus

    Reus, 43204

  • Corporació Sanitària Parc Taulí

    Sabadell

  • Hospital Clínico de Salamanca

    Salamanca, 37007

  • Hospital U. Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Marqués de Valdecillas

    Santander, 39008

  • Hospital Conxo

    Santiago de Compostela, 15706

  • Hospital General de Segovia

    Segovia, 40002

  • Hospital Virgen Macarena

    Seville, 41009

  • Hs. Virgen del Rocio

    Seville, 41013

  • Hospital Mutua Terrassa

    Terrassa, 08221

  • Hospital Virgen de la Salud Toledo

    Toledo, 45004

  • Hospital General de Valencia

    Valencia, 46014

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46014

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

  • Hospital Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Portugal3 sites

  • IPO Coimbra

    Coimbra, 300-075

  • IPO Lisboa

    Lisbon, 1099-023

  • Hospital São João

    Porto, 4200-319

Other trials in Portugal

About this study

Official title: 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.

Medical subject headings
Adenoma, Islet Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) rate at 24 months

    To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.

    Measured: 24 months

Secondary outcomes (10)

  1. Progression-free survival (PFS) rate at 12 months

    PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment

    Measured: 12 months

  2. Medical tumour-related intervention

    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

    Measured: Baseline

  3. Time from diagnosis to first therapeutic intervention

    Description of the disease history management of subjects with PanNET

    Measured: Baseline

  4. Quality of Life (QoL)

    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".

    Measured: From baseline up to 24 months

  5. Median time to lanreotide discontinuation

    Measured: Up to 24 months

  6. Changes of Chromogranin A (CgA) levels

    Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit

    Measured: Every 6 months up to 24 months

  7. Changes of Glycated hemoglobin (HbA1c) levels

    Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit

    Measured: Every 6 months up to 24 months

  8. Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels

    Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit

    Measured: Every 6 months up to 24 months

  9. Changes of pro-Brain Natriuretic Peptide (proBNP) levels

    Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit

    Measured: Every 6 months up to 24 months

  10. Patient satisfaction

    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).

    Measured: Baseline visit and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2019
  2. Study start3 Jul 2019
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Why it stopped: Low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03947762
Sponsor's protocol ID
A-ES-52030-383
Other IDs
IPS-LAN-2018-01
Acronym
PanNET
Status last verified
Jun 2021
First submitted
10 May 2019
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Neuroendocrine Tumor, run by Ipsen at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Spain, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) rate at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03947762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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