Somatostatin analog
DrugSomatostatin analog treatment every 4 weeks
Other names: lanreotide, octreotide, sandostatin, somatuline
NCT Number: NCT05701241
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)).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
AZ Klina, Brasschaat, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Somatostatin analog treatment every 4 weeks
Other names: lanreotide, octreotide, sandostatin, somatuline
Time frame: 18 months after start second-line treatment
PFS
Time frame: 18 months after start second-line treatment
TTD
Time frame: 18 months after start second-line treatment
PFS rate
Time frame: 18 months after start second-line treatment
PFS
Time frame: 18 months after start second-line treatment
TTD
Time frame: Time until death; assessed up to 5 years after treatment phase
OS
Time frame: Time until death; assessed up to 5 years after treatment phase
OS
Time frame: 18 months after start second-line treatment
RR
Time frame: 18 months after start second-line treatment
RR
Time frame: End of study (6.5 years after start second-line treatment)
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
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)
Time frame: End of study (6.5 years after start second-line treatment)
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Time frame: End of study (6.5 years after start second-line treatment)
Health technology assessment (HTA) analysis
Time frame: 18 months after start second-line treatment
Safety will be reported in terms of incidence and severity of (serious) adverse events
Contact information is provided by the study sponsor or research team.
University Hospital, Antwerp
Other
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Acronym: SAUNA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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