Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 54
- 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
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 Median time to lanreotide discontinuation Up to 24 months 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
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)
Hospital Basurto
🇪🇸Bilbao, Spain
Hospital General Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Torrecardenas
🇪🇸Almería, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Clínico U. Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Universitario Vall Hebrón
🇪🇸Barcelona, Spain
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Spain
Hospital Donostia
🇪🇸Donostia, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
IPO Lisboa
🇵🇹Lisboa, Portugal
Hospital Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Sant Joan de Reus
🇪🇸Reus, Spain
Hospital Conxo
🇪🇸Santiago De Compostela, Spain
Hospital Clínico de Salamanca
🇪🇸Salamanca, Spain
Hospital Can Misses
🇪🇸Ibiza, Spain
Hospital Marqués de Valdecillas
🇪🇸Santander, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hs. Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Virgen de la Salud Toledo
🇪🇸Toledo, Spain
Hospital Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital de Cruces
🇪🇸Baracaldo, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Mutua Terrassa
🇪🇸Terrassa, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
IPO Coimbra
🇵🇹Coimbra, Portugal
Hospital São João
🇵🇹Porto, Portugal
ICO Badalona
🇪🇸Badalona, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
ICO Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital Juan Ramón Jimenez
🇪🇸Huelva, Spain
Hospital de Jerez
🇪🇸Jerez De La Frontera, Spain
Hospital U. de Gran Canaria Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Virgen de La Victoria
🇪🇸Málaga, Spain
Hospital Santa María Nai
🇪🇸Ourense, Spain
Hospital U. Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitario Puerto Real
🇪🇸Cadiz, Spain