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

Neuroendocrine Tumours Clinical Trial

— PRELUDE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02788578
• Other study ID #: F-FR-52030-344
• Status: Terminated
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Neuroendocrine Tumours

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne
France	IUCT Oncopole	Toulouse
France	Institut Gustave Roussy	Villejuif
Germany	Zentralklinil Bad Berka	Bad Berka
Germany	Charité	Berlin
Germany	Klinikum rechts der Usar	München
Italy	Unversità degli Studi di Messina	Messina
Italy	IEO Institutio Europeo di Oncologia	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS rate as per RECIST (Version 1.1)		Up to 12 months post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of vomiting (during infusion only)		Approximately 3 to 6 months after the last PRRT/LAN ATG cycle