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

Ipsen54 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Neuroendocrine Tumor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Progression-free survival (PFS) rate at 12 months

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

Time frame: 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

Time frame: Baseline

Time from diagnosis to first therapeutic intervention

Description of the disease history management of subjects with PanNET

Time frame: 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".

Time frame: From baseline up to 24 months

Median time to lanreotide discontinuation

Time frame: 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

Data from ClinicalTrials.gov

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IPO Coimbra

Coimbra, Portugal

IPO Lisboa

Lisbon, Portugal

Hospital São João

Porto, Portugal

Hospital General de Alicante

Alicante, Spain

Hospital Torrecardenas

Almería, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

ICO Badalona

Badalona, Spain

Hospital de Cruces

Barakaldo, Spain

Hospital Universitario Vall Hebrón

Barcelona, Spain

Hospital Santa Creu I Sant Pau

Barcelona, Spain

...and 36 more locations