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

Sponsor

Ipsen (Industry)

Overall Status

Terminated

CT.gov ID

NCT03947762

Collaborator

(none)

Enrollment

Locations

21.9

Actual Duration (Months)

1.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neuroendocrine Tumor

Study Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 3, 2019

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Outcome Measures

Primary Outcome Measures

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

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
Time from diagnosis to first therapeutic intervention [Baseline]
Description of the disease history management of subjects with PanNET
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".
Median time to lanreotide discontinuation [Up to 24 months]
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 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
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
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
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	IPO Coimbra	Coimbra	Portugal	300-075
2	IPO Lisboa	Lisboa	Portugal	1099-023
3	Hospital São João	Porto	Portugal	4200-319
4	Hospital General de Alicante	Alicante	Spain	03010
5	Hospital Torrecardenas	Almería	Spain	04009
6	Hospital Universitario de Badajoz	Badajoz	Spain	06010
7	ICO Badalona	Badalona	Spain	08916
8	Hospital de Cruces	Baracaldo	Spain	48903
9	Hospital Universitario Vall Hebrón	Barcelona	Spain	08035
10	Hospital Santa Creu I Sant Pau	Barcelona	Spain
11	Hospital Basurto	Bilbao	Spain	48013
12	Hospital Universitario de Burgos	Burgos	Spain	09006
13	Hospital Universitario Puerto Real	Cadiz	Spain	11510
14	Hospital General Ciudad Real	Ciudad Real	Spain	13005
15	Hospital San Pedro de Alcántara	Cáceres	Spain	10003
16	Hospital Universitario Reina Sofia	Córdoba	Spain	14004
17	Hospital Donostia	Donostia	Spain	20014
18	Hospital Virgen de las Nieves	Granada	Spain	18014
19	ICO Bellvitge	Hospitalet de Llobregat	Spain	08908
20	Hospital Juan Ramón Jimenez	Huelva	Spain	21005
21	Hospital Can Misses	Ibiza	Spain	07800
22	Hospital de Jerez	Jerez De La Frontera	Spain	11407
23	Hospital U. de Gran Canaria Negrín	Las Palmas De Gran Canaria	Spain	35010
24	Hospital Clínico U. Virgen de la Arrixaca	Murcia	Spain	30120
25	Hospital Morales Meseguer	Murcia	Spain
26	Hospital Virgen de La Victoria	Málaga	Spain	29010
27	Hospital Santa María Nai	Ourense	Spain	32005
28	Hospital Universitario Central de Asturias	Oviedo	Spain	33011
29	Hospital Son Espases	Palma De Mallorca	Spain	07120
30	Hospital de Navarra	Pamplona	Spain	31008
31	Hospital Sant Joan de Reus	Reus	Spain	43204
32	Corporació Sanitària Parc Taulí	Sabadell	Spain
33	Hospital Clínico de Salamanca	Salamanca	Spain	37007
34	Hospital U. Nuestra Señora de Candelaria	Santa Cruz De Tenerife	Spain	38010
35	Hospital Marqués de Valdecillas	Santander	Spain	39008
36	Hospital Conxo	Santiago De Compostela	Spain	15706
37	Hospital General de Segovia	Segovia	Spain	40002
38	Hospital Virgen Macarena	Sevilla	Spain	41009
39	Hs. Virgen del Rocio	Sevilla	Spain	41013
40	Hospital Mutua Terrassa	Terrassa	Spain	08221
41	Hospital Virgen de la Salud Toledo	Toledo	Spain	45004
42	Hospital General de Valencia	Valencia	Spain	46014
43	Hospital Universitario y Politécnico La Fe	Valencia	Spain	46014
44	Hospital Álvaro Cunqueiro	Vigo	Spain	36312
45	Hospital Lozano Blesa	Zaragoza	Spain	50009
46	Hospital Miguel Servet	Zaragoza	Spain	50009

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT03947762

Other Study ID Numbers:

A-ES-52030-383
IPS-LAN-2018-01

First Posted:

May 13, 2019

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Adenoma, Islet Cell

Study Results

No Results Posted as of Jun 14, 2021