About this trial
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)).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Somatostatin analog
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
Erasmus Medical Center
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Belgium Health Care Knowledge Centre
Collaborator