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A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours (PRELUDE)

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ClinicalTrials.gov Identifier: NCT02788578
Recruitment Status : Terminated (The study terminated prematurely due to insufficient recruitment.)
First Posted : June 2, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.

Condition or disease
Neuroendocrine Tumours

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours
Actual Study Start Date : June 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017





Primary Outcome Measures :
  1. Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1) [ Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle ]

Secondary Outcome Measures :
  1. PFS rate as per RECIST (Version 1.1) [ Time Frame: Up to 12 months post-treatment ]
  2. Best Overall Response as per RECIST (Version 1.1) [ Time Frame: Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier ]
  3. Objective Response Rate as per RECIST (Version 1.1) [ Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment ]
  4. Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the presence and in the severity of diarrhoea and flushing, if any [ Time Frame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment ]
  5. Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the tumour biomarker CgA [ Time Frame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle ]
  6. Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight [ Time Frame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment ]
  7. Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders) [ Time Frame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment ]
  8. Incidence of vomiting (during infusion only) [ Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle ]


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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:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Histopathologically confirmed metastatic well differentiated Neuroendocrine Tumour (NET) (Grade G1 or G2 according to the World Health Organisation 2010 classification): Gastro-entero-pancreatic (GEP) or Bronchopulmonary (BP) primary tumour, or tumour of unknown origin believed to be of GEP origin, if a primary tumour elsewhere was excluded by multiphasic computerised tomography (CT) or magnetic resonance imaging (MRI)
  • Disease progression radiologically documented with evaluable imaging (CT or MRI, digital or print-out), performed within 12 months and within 6 months prior to the first PRRT/LAN ATG cycle
  • Metastatic- or locally-advanced, hormonal functioning or nonfunctioning GEP-NET or BP-NET;
  • Confirmed presence of Somatostatin Receptors (SSTRs) on all target lesions based on positive SSTR scintigraphy (Octreoscan®/99mTC-tektrotyd) or 68Ga SSTR Positron Emission Tomography-Computerised Tomography (PET/CT) imaging, i.e. Grade ≥2 respectively per the Krenning scale or per the modified Krenning scale

Exclusion Criteria:

  • Absence of information regarding LAN ATG treatment: dose received, start date, frequency of injections
  • No CT or MRI within 12 months and within 6 months preceding the baseline, or at the end of the last PRRT/LAN ATG cycle
  • Absence of information on cumulative activity of PRRT with 177 Lutetium (177Lu) DOTATOC or 177Lu-DOTATATE received (at least 500 mCi (equivalent to 18.5 GBq), for the entire therapy)
  • PRRT prior to the first combination cycle of PRRT/LAN ATG

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): NCT02788578


Locations
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Australia
Peter MacCallum Cancer Centre
East Melbourne, Australia
France
IUCT Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Germany
Zentralklinil Bad Berka
Bad Berka, Germany
Charité
Berlin, Germany
Klinikum rechts der Usar
München, Germany
Italy
Unversità degli Studi di Messina
Messina, Italy
IEO Institutio Europeo di Oncologia
Milano, Italy
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Free Hospital London
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
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: NCT02788578     History of Changes
Other Study ID Numbers: F-FR-52030-344
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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