Testing whether continuing somatostatin analogues helps neuroendocrine tumour patients after progression
Tests continuing somatostatin analogues in adults with advanced gastroenteropancreatic neuroendocrine tumours that progressed.
Plain-language title generated from the registry record
Registry title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Key facts
- Where
- Antwerp, Brasschaat, Brussels, Charleroi, Edegem, Ghent, Leuven, Liège, Rumst, and Sint-Niklaas, BelgiumSee the 13 sites
- Phase
- Phase 4
Where in Belgium
- AZ MonicaAntwerp, BelgiumNot yet recruiting
- GZAAntwerp, BelgiumNo longer taking part
- Ziekenhuis Netwerk AntwerpenAntwerp, BelgiumNo longer taking part
- AZ KLINABrasschaat, BelgiumTaking people
- Cliniques universitaires Saint-LucBrussels, BelgiumTaking people
- H.U.B.Brussels, BelgiumNo longer taking part
- Grand Hopital de CharleroiCharleroi, BelgiumNo longer taking part
- Antwerp University HospitalEdegem, BelgiumTaking people
- Ghent university hospitalGhent, BelgiumNo longer taking part
- University Hospital LeuvenLeuven, BelgiumTaking people
- Centre Hospitalier Universitaire Sart TilmanLiège, BelgiumNo longer taking part
- AZ RivierenlandRumst, BelgiumNo longer taking part
- VitazSint-Niklaas, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Antwerp
- Trial code
- NCT05701241
- Record updated
- 14 June 2024
- Original description
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)).Read full original descriptionShow less
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA 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)).
Inclusion: 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; Documented radiological disease progression on first-line SSA treatment at label dose or higher; For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator; For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator.
Exclusion: Indication for chemotherapy treatment of GEP NET in second-line; Prior treatment with everolimus, sunitinib or PRRT; Concurrent anti-cancer treatment in another investigational trial; Contra-indication, proven allergy or other indication than functional NET for the use of a SSA; Patient showing progressive disease while being on a lower than the registered dose; Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome; Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET; Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study; Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET; Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial.