Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Status:
Not yet recruiting
Trial end date:
2034-04-01
Target enrollment:
Participant gender:
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)).
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Antwerp
Collaborators:
Belgium Health Care Knowledge Centre Erasmus Medical Center ZonMw: The Netherlands Organisation for Health Research and Development