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

December 20, 2018 updated by: Ipsen

Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia
        • Peter MacCallum Cancer Centre
  • France
      • Toulouse, France
        • IUCT Oncopole
      • Villejuif, France
        • Institut Gustave Roussy
  • Germany
      • Bad Berka, Germany
        • Zentralklinil Bad Berka
      • Berlin, Germany
        • Charité
      • München, Germany
        • Klinikum rechts der Usar
  • Italy
      • Messina, Italy
        • Unversità degli Studi di Messina
      • Milano, Italy
        • IEO Institutio Europeo di Oncologia
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital Birmingham
      • London, United Kingdom
        • Kings College Hospital
      • London, United Kingdom
        • Royal Free Hospital London
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS rate as per RECIST (Version 1.1)
Time Frame: Up to 12 months post-treatment
Up to 12 months post-treatment
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
Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier
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
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
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
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
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
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle
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
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
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
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Incidence of vomiting (during infusion only)
Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-FR-52030-344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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