DRUG
Somatostatin analog
Somatostatin analog treatment every 4 weeks
Status
Recruiting
Phase
Phase 4
Enrollment
270
Locations
19
Results
Not posted
Publications
1
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)).
Interventions
DRUG
Somatostatin analog treatment every 4 weeks
Timeline
First posted
Jan 27, 2023
Study start
Jun 28, 2023
Primary completion
Apr 2029
Study completion
Apr 2034
Results posted
Not reported
Registry updated
Jun 14, 2024
Outcomes
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
Time frame · 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
Time frame · 18 months after start second-line treatment
TTD
progression-free survival rate according to RECIST 1.1
Time frame · 18 months after start second-line treatment
PFS rate
The difference in a pooled progression-free survival of both substudies
Time frame · 18 months after start second-line treatment
PFS
The difference in a pooled time to deterioration of both substudies
Time frame · 18 months after start second-line treatment
TTD
Overall survival (OS) per substudy and pooled over both substudies
Time frame · Time until death; assessed up to 5 years after treatment phase
OS
Overall survival pooled over both substudies
Time frame · Time until death; assessed up to 5 years after treatment phase
OS
Response rates (RR) per substudy
Time frame · 18 months after start second-line treatment
RR
Response rates over both substudies
Time frame · 18 months after start second-line treatment
RR
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Eligibility
Inclusion Criteria: * Age ≥18 years * Written informed consent prior to any study-related procedures * Eastern Cooperative Oncology Group (ECOG) performance status ≤2, * Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET * Documented radiological disease progression on first-line SSA treatment at label dose or higher * For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator * For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator Exclusion Criteria: * Indication for chemotherapy treatment of GEP NET in second-line * Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET * Prior treatment with everolimus, sunitinib or PRRT * Contra-indication, proven allergy or other indication than functional NET for the use of a SSA * Patient showing progressive disease while being on a lower than the registered dose * Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome * Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET * Concurrent anti-cancer treatment in another investigational trial * Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study * Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
Study locations
Belgium · Netherlands. Showing up to 24 locations stored in the fast local snapshot.
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
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