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

Terminated

• Conditions: Neuroendocrine Tumours

• Registration Number: NCT02788578
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-05-27
• Study Start: 2016-06
• Study First Posted: 2016-06-02
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PFS rate as per RECIST (Version 1.1)	Up to 12 months post-treatment
Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders)	Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and 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
Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight	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 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
Incidence of vomiting (during infusion only)	Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
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 tumour biomarker CgA	Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Trial Locations

Locations (12)

IUCT Oncopole; 🇫🇷 Toulouse, France

Unversità degli Studi di Messina; 🇮🇹 Messina, Italy

Zentralklinil Bad Berka; 🇩🇪 Bad Berka, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Australia

IEO Institutio Europeo di Oncologia; 🇮🇹 Milano, Italy

Klinikum rechts der Usar; 🇩🇪 München, Germany

Kings College Hospital; 🇬🇧 London, United Kingdom

Royal Free Hospital London; 🇬🇧 London, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Charité; 🇩🇪 Berlin, Germany

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom