Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice

Neuroendocrine Tumors Clinical Trial

— NETways  

Official title:

Prospective Noninterventional Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Tumours (GEP-NETs) in Routine Clinical Practice

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03895463
• Other study ID #: A-PL-52030-380
• Status: Withdrawn
• Start date: August 2019
• Est. completion date: March 26, 2023

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 26, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Functioning or non-functioning histopathologically confirmed, locally advanced or metastatic (grade 1 or grade 2 according to the World Health Organisation (WHO) 2017 classification and European Neuroendocrine Tumour Society (ENETS) grading system) GEP-NET G1,G2 (Ki67=10%, based on recent Ki67).
• Measurable disease, as defined by RECIST 1.0, on a CT scan/MRI obtained up to 6 weeks prior to initiation of treatment with Lanreotide Autogel 120 mg.
• Subject eligible for treatment with Lanreotide Autogel 120 mg or subject currently being treated with Lanreotide Autogel 120 mg administered every 28 days for a period no longer than 5 months prior to inclusion
• Treatment with Lanreotide Autogel 120 mg alone, according to local Summary of Product Characteristics (SmPC).

Exclusion Criteria:

• Lanreotide Autogel treatment for more than 5 months prior to inclusion into the study
• Concomitant anti-proliferative medication/therapies for GEP NET at initiation of Lanreotide Autogel treatment (e.g. Peptide Receptor Radionuclide Therapy (PRRT), cytotoxic chemotherapy, targeted therapy everolimus, sunitinib, interferon, loperamide).
• Has been treated with PRRT, chemotherapy, everolimus, sunitinib or interferon within 3 months prior to initiation of Lanreotide Autogel treatment
• Parallel participation in an interventional study

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Locations

Country	Name	City	State
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach	Gliwice
Poland	Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Swietokrzyskie Centrum Onkologii	Kielce
Poland	Szpital Uniwersytecki w Krakowie	Kraków
Poland	SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego w Poznaniu	Poznan
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokolowskiego	Szczecin
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warsaw
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny	Warsaw
Poland	Dolnoslaskie Centrum Onkologii we Wroclawiu	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	To estimate the rate according to investigator assessment (radiological progression; based on Response Evaluation Criteria In Solid Tumours version 1.0 [RECIST 1.0])	12 months
Secondary	Median PFS		24 months
Secondary	Tumour origin		24 months
Secondary	Tumour grade		24 months
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".	24 months
Secondary	Disease Control Rate	To estimate the Disease Control Rate (DCR), as assessed by investigator (proportion of subjects with a best overall response of Partial Response [PR], Complete Response [CR] or Stable Disease [SD]).	24 months
Secondary	Chromogranin A (CgA) level		24 months
Secondary	Patients' satisfaction	To evaluate patients' satisfaction using abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). It assesses key dimensions of treatment satisfaction: 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).	24 months
Secondary	Urine 5-hydroxyindoleaceticacid (5-HIAA) levels		24 months