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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Somatostatin analog treatment every 4 weeks
AZ Klina
Brasschaat, Antwerp, Belgium
RECRUITINGAZ Rivierenland
Rumst, Antwerp, Belgium
ACTIVE_NOT_RECRUITINGGhent University Hospital
Ghent, East Flanders, Belgium
ACTIVE_NOT_RECRUITINGVITAZ
Sint-Niklaas, East-Flanders, Belgium
RECRUITINGUniversity Hospital Leuven
Leuven, Flemish Brabant, Belgium
RECRUITINGGrand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
ACTIVE_NOT_RECRUITINGAZ Monica
Antwerp, Belgium
NOT_YET_RECRUITINGGZA
Antwerp, Belgium
ACTIVE_NOT_RECRUITINGZiekenhuis Netwerk Antwerpen
Antwerp, Belgium
WITHDRAWNCliniques Universitaires Saint-Luc
Brussels, Belgium
RECRUITING...and 9 more locations
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
PFS
Time frame: 18 months after start second-line treatment
The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy
TTD
Time frame: 18 months after start second-line treatment
progression-free survival rate according to RECIST 1.1
PFS rate
Time frame: 18 months after start second-line treatment
The difference in a pooled progression-free survival of both substudies
PFS
Time frame: 18 months after start second-line treatment
The difference in a pooled time to deterioration of both substudies
TTD
Time frame: 18 months after start second-line treatment
Overall survival (OS) per substudy and pooled over both substudies
OS
Time frame: Time until death; assessed up to 5 years after treatment phase
Overall survival pooled over both substudies
OS
Time frame: Time until death; assessed up to 5 years after treatment phase
Response rates (RR) per substudy
RR
Time frame: 18 months after start second-line treatment
Response rates over both substudies
RR
Time frame: 18 months after start second-line treatment
Quality of life (QoL) measurement with questionnaire
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
Time frame: End of study (6.5 years after start second-line treatment)
Quality of life (QoL) measurement with questionnaire
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
Time frame: End of study (6.5 years after start second-line treatment)
Quality of life (QoL) measurement with questionnaire
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Time frame: End of study (6.5 years after start second-line treatment)
Cost-effectiveness
Health technology assessment (HTA) analysis
Time frame: End of study (6.5 years after start second-line treatment)
Drug safety
Safety will be reported in terms of incidence and severity of (serious) adverse events
Time frame: 18 months after start second-line treatment
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