Progression-Free Survival (PFS)
Time frame · 12 months
To estimate the rate according to investigator assessment (radiological progression; based on Response Evaluation Criteria In Solid Tumours version 1.0 \[RECIST 1.0\])
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
Status
Withdrawn
Phase
Not applicable
Enrollment
0
Locations
11
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Mar 29, 2019
Study start
Aug 2019
Primary completion
Mar 26, 2023
Study completion
Mar 26, 2023
Results posted
Not reported
Registry updated
Nov 5, 2020
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
Median PFS
Time frame · 24 months
Tumour origin
Time frame · 24 months
Tumour grade
Time frame · 24 months
Quality of Life (QoL)
Time frame · 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".
Disease Control Rate
Time frame · 24 months
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 \[SD\]).
Chromogranin A (CgA) level
Time frame · 24 months
Patients' satisfaction
Time frame · 24 months
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).
Urine 5-hydroxyindoleaceticacid (5-HIAA) levels
Time frame · 24 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
11 registered sites.
Poland. Showing up to 24 locations stored in the fast local snapshot.
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach
Gliwice, Poland
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
Świętokrzyskie Centrum Onkologii
Kielce, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu
Poznan, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
Szczecin, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny
Warsaw, Poland
Dolnośląskie Centrum Onkologii we Wrocławiu
Wroclaw, Poland
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Lanreotide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Put the record in context.
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