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.
Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.
Status
Terminated
Phase
Not applicable
Enrollment
54
Locations
46
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
May 13, 2019
Study start
Jul 3, 2019
Primary completion
Apr 30, 2021
Study completion
Apr 30, 2021
Results posted
Not reported
Registry updated
Jun 14, 2021
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
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
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
Time from diagnosis to first therapeutic intervention
Time frame · Baseline
Description of the disease history management of subjects with PanNET
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".
Median time to lanreotide discontinuation
Time frame · 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
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
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
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
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).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
46 registered sites.
Portugal · Spain. Showing up to 24 locations stored in the fast local snapshot.
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
Hospital Basurto
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Puerto Real
Cadiz, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital General Ciudad Real
Ciudad Real, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Donostia
Donostia / San Sebastian, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Juan Ramón Jimenez
Huelva, Spain
Hospital Can Misses
Ibiza Town, Spain
Hospital de Jerez
Jerez de la Frontera, Spain
ICO Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital U. de Gran Canaria Negrín
Las Palmas de Gran Canaria, Spain
Hospital Virgen de La Victoria
Málaga, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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