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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Ipsen
- Locations
- 11
- Primary Endpoint
- Progression-Free Survival (PFS)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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 \[RECIST 1.0\])
Secondary Outcomes
- Tumour origin(24 months)
- Tumour grade(24 months)
- Quality of Life (QoL)(24 months)
- Patients' satisfaction(24 months)
- Urine 5-hydroxyindoleaceticacid (5-HIAA) levels(24 months)
- Chromogranin A (CgA) level(24 months)
- Median PFS(24 months)
- Disease Control Rate(24 months)