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 Type
OBSERVATIONAL
Enrollment
40
Peter MacCallum Cancer Centre
East Melbourne, Australia
IUCT Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Zentralklinil Bad Berka
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
PFS rate as per RECIST (Version 1.1)
Time frame: 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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bad Berka, Germany
Charité
Berlin, Germany
Klinikum rechts der Usar
München, Germany
Unversità degli Studi di Messina
Messina, Italy
IEO Institutio Europeo di Oncologia
Milan, Italy
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Kings College Hospital
London, United Kingdom
...and 2 more locations
Incidence of vomiting (during infusion only)
Time frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle