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

Terminated

• Conditions: Pancreatic Neuroendocrine Tumor

• Registration Number: NCT03947762
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2019-07-03
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) rate at 24 months	24 months	To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.

Secondary Outcome Measures

Name	Time	Method
Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels	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
Progression-free survival (PFS) rate at 12 months	12 months	PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment
Medical tumour-related intervention	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
Changes of Chromogranin A (CgA) levels	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
Changes of pro-Brain Natriuretic Peptide (proBNP) levels	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
Time from diagnosis to first therapeutic intervention	Baseline	Description of the disease history management of subjects with PanNET
Median time to lanreotide discontinuation	Up to 24 months
Changes of Glycated hemoglobin (HbA1c) levels	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
Quality of Life (QoL)	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".
Patient satisfaction	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).

Trial Locations

Locations (46)

IPO Coimbra; 🇵🇹 Coimbra, Portugal

IPO Lisboa; 🇵🇹 Lisboa, 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; 🇪🇸 Baracaldo, Spain

Hospital Universitario Vall Hebrón; 🇪🇸 Barcelona, Spain

Hospital Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

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