Neuroendocrine Tumours
Conditions
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 (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 tumour biomarker CgA | Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle |
| 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 |
| Incidence of vomiting (during infusion only) | Approximately 3 to 6 months after the last PRRT/LAN ATG cycle |
| 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 |
Countries
Australia, France, Germany, Italy, United Kingdom
Outcome results
None listed