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

Pancreatic Neuroendocrine Tumor Clinical Trial

— PanNET  

Official title:

Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03947762
• Other study ID #: A-ES-52030-383
• Secondary ID: IPS-LAN-2018-01
• Status: Terminated
• Start date: July 3, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Locations

Country	Name	City	State
Portugal	IPO Coimbra	Coimbra
Portugal	IPO Lisboa	Lisboa
Portugal	Hospital São João	Porto
Spain	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 Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Vall Hebrón	Barcelona
Spain	Hospital Basurto	Bilbao
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario Puerto Real	Cadiz
Spain	Hospital General Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Donostia	Donostia
Spain	Hospital Virgen de las Nieves	Granada
Spain	ICO Bellvitge	Hospitalet de Llobregat
Spain	Hospital Juan Ramón Jimenez	Huelva
Spain	Hospital Can Misses	Ibiza
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 Clínico U. Virgen de la Arrixaca	Murcia
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Santa María Nai	Ourense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Espases	Palma De Mallorca
Spain	Hospital de Navarra	Pamplona
Spain	Hospital Sant Joan de Reus	Reus
Spain	Corporació Sanitària Parc Taulí	Sabadell
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital U. Nuestra Señora de Candelaria	Santa Cruz De Tenerife
Spain	Hospital Marqués de Valdecillas	Santander
Spain	Hospital Conxo	Santiago De Compostela
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hs. Virgen del Rocio	Sevilla
Spain	Hospital Mutua Terrassa	Terrassa
Spain	Hospital Virgen de la Salud Toledo	Toledo
Spain	Hospital General de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Álvaro Cunqueiro	Vigo
Spain	Hospital Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival (PFS) rate at 12 months	PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment	12 months
Secondary	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
Secondary	Time from diagnosis to first therapeutic intervention	Description of the disease history management of subjects with PanNET	Baseline
Secondary	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
Secondary	Median time to lanreotide discontinuation		Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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