Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor
- Interventions
- Registration Number
- NCT05701241
- Lead Sponsor
- University Hospital, Antwerp
- Brief 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)).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- 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
- 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
- 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
- Concurrent anti-cancer treatment in another investigational trial
- 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
- Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description somatostatin analogs continuation Somatostatin analog Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.
- Primary Outcome Measures
Name Time Method the difference in progression-free survival (PFS) in patients continuing or stopping second-line therapy with SSAs, as assessed by the blinded local investigator on cross-sectional imaging, according to RECIST 1.1 criteria per substudy 18 months after start second-line treatment PFS
The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy 18 months after start second-line treatment TTD
- Secondary Outcome Measures
Name Time Method Overall survival pooled over both substudies Time until death; assessed up to 5 years after treatment phase OS
Response rates (RR) per substudy 18 months after start second-line treatment RR
Response rates over both substudies 18 months after start second-line treatment RR
Quality of life (QoL) measurement with questionnaire End of study (6.5 years after start second-line treatment) QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Cost-effectiveness End of study (6.5 years after start second-line treatment) Health technology assessment (HTA) analysis
Drug safety 18 months after start second-line treatment Safety will be reported in terms of incidence and severity of (serious) adverse events
Overall survival (OS) per substudy and pooled over both substudies Time until death; assessed up to 5 years after treatment phase OS
progression-free survival rate according to RECIST 1.1 18 months after start second-line treatment PFS rate
The difference in a pooled progression-free survival of both substudies 18 months after start second-line treatment PFS
The difference in a pooled time to deterioration of both substudies 18 months after start second-line treatment TTD
Trial Locations
- Locations (19)
Amsterdam UMC
🇳🇱Amsterdam, North Holland, Netherlands
Centre Hospitalier Universitaire Sart Tilman
🇧🇪Liège, Belgium
Rijnstate
🇳🇱Arnhem, Gelderland, Netherlands
University Hospital Leuven
🇧🇪Leuven, Flemish Brabant, Belgium
Ziekenhuis Netwerk Antwerpen
🇧🇪Antwerpen, Belgium
VITAZ
🇧🇪Sint-Niklaas, East-Flanders, Belgium
Maastricht UMC+
🇳🇱Maastricht, Limburg, Netherlands
Ghent University Hospital
🇧🇪Ghent, East Flanders, Belgium
Grand Hôpital de Charleroi
🇧🇪Charleroi, Hainaut, Belgium
UMC Groningen
🇳🇱Groningen, Netherlands
AZ Klina
🇧🇪Brasschaat, Antwerp, Belgium
Maxima Medisch Centrum
🇳🇱Eindhoven, North Brabant, Netherlands
AZ Rivierenland
🇧🇪Rumst, Antwerp, Belgium
H.U.B.
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussel, Belgium
Erasmus MC
🇳🇱Rotterdam, Netherlands
AZ Monica
🇧🇪Antwerpen, Belgium
GZA
🇧🇪Antwerp, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium