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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)

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ClinicalTrials.gov Identifier: NCT03895463
Recruitment Status : Withdrawn (Reassessment of study feasibility)
First Posted : March 29, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date March 27, 2019
First Posted Date March 29, 2019
Last Update Posted Date August 6, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date March 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2019)
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])
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03895463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 3, 2019)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: March 27, 2019)
  • 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) QLQ-GINET21 questionnaires
  • 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 (abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)).
  • Urine 5-hydroxyindoleaceticacid (5-HIAA) levels [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: August 2, 2019)
0
Original Estimated Enrollment
 (submitted: March 27, 2019)
271
Estimated Study Completion Date March 26, 2023
Estimated Primary Completion Date March 26, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03895463
Other Study ID Numbers A-PL-52030-380
2018-002149-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date August 2019