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RECRUITING
NCT05701241
PHASE4

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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

DRUG

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