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

NCT02788578 | Terminated

• 1 other identifier: F-FR-52030-344
• Study Type: observational
• Target: 40
• Locations: 5 countries
• Sites: 12

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.

Conditions

Neuroendocrine Tumours

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)

  Approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Secondary Outcomes (8)

• PFS rate as per RECIST (Version 1.1)

  Up to 12 months post-treatment

• Best Overall Response as per RECIST (Version 1.1)

  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)

  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

  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

  Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (12)

Peter MacCallum Cancer Centre

East Melbourne, Australia

Location

IUCT Oncopole

Toulouse, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Zentralklinil Bad Berka

Bad Berka, Germany

Location

Charité

Berlin, Germany

Location

Klinikum rechts der Usar

München, Germany

Location

Unversità degli Studi di Messina

Messina, Italy

Location

IEO Institutio Europeo di Oncologia

Milan, Italy

Location

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Royal Free Hospital London

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• Prasad V, Srirajaskanthan R, Toumpanakis C, Grana CM, Baldari S, Shah T, Lamarca A, Courbon F, Scheidhauer K, Baudin E, Truong Thanh XM, Houchard A, Dromain C, Bodei L. Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2358-2371. doi: 10.1007/s00259-020-04712-2. Epub 2020 Feb 15.

  PMID: 32062681 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

AU (1); IT (2); DE (3); FR (2); GB (4)