Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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)).

NCT Number	NCT05701241
Lead Sponsor	University Hospital, Antwerp Collaborators: Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre
Conditions	Gastroenteropancreatic Neuroendocrine Tumor
Enrollment	270 participants
Start Date	2023-06-28
Primary Completion	2029-04 (estimated)
Study Completion	2034-04 (estimated)
Updated on ClinicalTrials.gov	2024-06-14