Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Condition(s) studied
Investigational drug(s) / intervention(s)
Somatostatin analog: Somatostatin analog treatment every 4 weeks
Study 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)).
Eligibility
Primary outcome measure(s)
- the difference in progression-free survival (PFS) in patients continuing or stopping second-line therapy with SSAs, as assessed by the blinded local investigator on cross-sectional imaging, according to RECIST 1.1 criteria per substudy — 18 months after start second-line treatment
PFS - The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy — 18 months after start second-line treatment
TTD
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| AZ Klina | Brasschaat | Antwerp | Recruiting |
| AZ Rivierenland | Rumst | Antwerp | Active Not Recruiting |
| Ghent University Hospital | Ghent | East Flanders | Active Not Recruiting |
| VITAZ | Sint-Niklaas | East-Flanders | Recruiting |
| University Hospital Leuven | Leuven | Flemish Brabant | Recruiting |
| Grand Hôpital de Charleroi | Charleroi | Hainaut | Active Not Recruiting |
| AZ Monica | Antwerp | Belgium | Not Yet Recruiting |
| GZA | Antwerp | Belgium | Active Not Recruiting |
| Ziekenhuis Netwerk Antwerpen | Antwerp | Belgium | Withdrawn |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| H.U.B. | Brussels | Belgium | Active Not Recruiting |
| Antwerp University Hospital | Edegem | Belgium | Recruiting |
| Centre Hospitalier Universitaire Sart Tilman | Liège | Belgium | Active Not Recruiting |
| Rijnstate | Arnhem | Gelderland | Recruiting |
| Maastricht UMC+ | Maastricht | Limburg | Recruiting |
| Maxima Medisch Centrum | Eindhoven | North Brabant | Active Not Recruiting |
| Amsterdam UMC | Amsterdam | North Holland | Active Not Recruiting |
| UMC Groningen | Groningen | Netherlands | Recruiting |
| Erasmus MC | Rotterdam | Netherlands | Recruiting |
More University Hospital, Antwerp trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05701241 on ClinicalTrials.gov ↗ ← All trials in Belgium