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

Study Overview

Lanreotide 120mg Effectiveness in Subjects With 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.

N/A

Pancreatic Neuroendocrine Tumor

A-ES-52030-383
IPS-LAN-2018-01 (OTHER Identifier) (OTHER: Spanish Drug Agency AEMPS)

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-05-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-06-09
First Submitted that Met QC Criteria 2019-05-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-14
First Posted (ACTUAL) 2019-05-13	Results First Posted N/A	Last Verified 2021-06

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival (PFS) rate at 12 months	PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment	12 months
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	Baseline
Time from diagnosis to first therapeutic intervention	Description of the disease history management of subjects with PanNET	Baseline
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".	From baseline up to 24 months
Median time to lanreotide discontinuation		Up to 24 months
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	Every 6 months up to 24 months
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	Every 6 months up to 24 months
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	Every 6 months up to 24 months
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	Every 6 months up to 24 months
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).	Baseline visit and 12 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Ipsen Medical Director, Ipsen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record