Spots Global Cancer Trial Database for Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
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Trial Identification
Brief Title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Official Title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Study ID: NCT05701241
Interventions
Study Description
Brief 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)).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Antwerpen, , Belgium
Ziekenhuis Netwerk Antwerpen, Antwerpen, , Belgium
GZA, Antwerp, , Belgium
H.U.B., Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussel, , Belgium
Antwerp University Hospital, Edegem, , Belgium
Centre Hospitalier Universitaire Sart Tilman, Liège, , Belgium
AZ Voorkempen, Malle, , Belgium
Rijstate, 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
Contact Details
Name: Marc Peeters, MD
Affiliation: University Hospital, Antwerp
Role: PRINCIPAL_INVESTIGATOR
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