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Trial record 89 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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 : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease
Neuroendocrine Tumors

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Study Type : Observational
Estimated Enrollment : 271 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 26, 2023
Estimated Study Completion Date : March 26, 2023





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Median PFS [ Time Frame: 24 months ]
  2. Tumour origin [ Time Frame: 24 months ]
  3. Tumour grade [ Time Frame: 24 months ]
  4. 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".

  5. 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]).

  6. Chromogranin A (CgA) level [ Time Frame: 24 months ]
  7. 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).

  8. Urine 5-hydroxyindoleaceticacid (5-HIAA) levels [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895463


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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Poland
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdańsk, Poland, 80952
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach Not yet recruiting
Gliwice, Poland, 44102
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach Not yet recruiting
Katowice, Poland, 40514
Świętokrzyskie Centrum Onkologii Not yet recruiting
Kielce, Poland, 25734
Szpital Uniwersytecki w Krakowie Not yet recruiting
Kraków, Poland, 31501
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu Not yet recruiting
Poznań, Poland, 60355
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego Not yet recruiting
Szczecin, Poland, 71252
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Not yet recruiting
Warsaw, Poland, 02034
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny Not yet recruiting
Warsaw, Poland, 02097
Dolnośląskie Centrum Onkologii we Wrocławiu Not yet recruiting
Wrocław, Poland, 53413
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi Not yet recruiting
Łódź, Poland, 92213
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03895463     History of Changes
Other Study ID Numbers: A-PL-52030-380
2018-002149-13 ( EudraCT Number )
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lanreotide
Angiopeptin
Antineoplastic Agents