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Neuroendocrine TumorsNETwaysNCT03895463

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

An observational study of Neuroendocrine Tumors, run by Ipsen at 11 sites in Poland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
How many people
0 participants
Where
11 sitesPoland
Study dates
Aug 2019to 26 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Poland11 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80952

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach

    Gliwice, 44102

  • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40514

  • Świętokrzyskie Centrum Onkologii

    Kielce, 25734

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31501

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz, 92213

  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu

    Poznan, 60355

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego

    Szczecin, 71252

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie

    Warsaw, 02034

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny

    Warsaw, 02097

  • Dolnośląskie Centrum Onkologii we Wrocławiu

    Wroclaw, 53413

Other trials in Poland

About this study

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

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.

Medical subject headings
Neuroendocrine Tumors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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])

    Measured: 12 months

Secondary outcomes (8)

  1. Median PFS

    Measured: 24 months

  2. Tumour origin

    Measured: 24 months

  3. Tumour grade

    Measured: 24 months

  4. 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".

    Measured: 24 months

  5. 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]).

    Measured: 24 months

  6. Chromogranin A (CgA) level

    Measured: 24 months

  7. 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).

    Measured: 24 months

  8. Urine 5-hydroxyindoleaceticacid (5-HIAA) levels

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study startAug 2019 (estimated)
  3. Primary completion26 Mar 2023 (estimated)
  4. Study completion26 Mar 2023 (estimated)

Why it stopped: Reassessment of study feasibility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895463
Sponsor's protocol ID
A-PL-52030-380
Acronym
NETways
Status last verified
Nov 2020
First submitted
27 Mar 2019
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Tumors, run by Ipsen at 11 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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