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 (NETways)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Neuroendocrine Tumors

• Study Type: Observational

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80952
    • Uniwersyteckie Centrum Kliniczne
  • Gliwice, Poland, 44102
    • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach
  • Katowice, Poland, 40514
    • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • Kielce, Poland, 25734
    • Swietokrzyskie Centrum Onkologii
  • Kraków, Poland, 31501
    • Szpital Uniwersytecki w Krakowie
  • Poznań, Poland, 60355
    • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu
  • Szczecin, Poland, 71252
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
  • Warsaw, Poland, 02034
    • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
  • Warsaw, Poland, 02097
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny
  • Wrocław, Poland, 53413
    • Dolnośląskie Centrum Onkologii we Wrocławiu
  • Łódź, Poland, 92213
    • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult subjects with GEP-NETs eligible for treatment with Lanreotide Autogel 120 mg or currently being treated with Lanreotide Autogel 120 mg every 28 days for a period of up to 5 months. Subjects will receive treatment as prescribed by the physician and in accordance with the current Summary of Product Characteristics (SmPC).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median PFS		24 months
Tumour origin		24 months
Tumour grade		24 months
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
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
Chromogranin A (CgA) level		24 months
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
Urine 5-hydroxyindoleaceticacid (5-HIAA) levels		24 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): March 26, 2023
• Study Completion (Anticipated): March 26, 2023

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: A-PL-52030-380

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No