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Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Sponsor: University Hospital, Antwerp
Summary
The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).
Official title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2023-06-28
Completion Date
2034-04
Last Updated
2024-06-14
Healthy Volunteers
No
Interventions
Somatostatin analog
Somatostatin analog treatment every 4 weeks
Locations (19)
AZ Klina
Brasschaat, Antwerp, Belgium
AZ Rivierenland
Rumst, Antwerp, Belgium
Ghent University Hospital
Ghent, East Flanders, Belgium
VITAZ
Sint-Niklaas, East-Flanders, Belgium
University Hospital Leuven
Leuven, Flemish Brabant, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
AZ Monica
Antwerp, Belgium
GZA
Antwerp, Belgium
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
H.U.B.
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium
Rijnstate
Arnhem, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Maxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
UMC Groningen
Groningen, Netherlands
Erasmus MC
Rotterdam, Netherlands