Actively Recruiting
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Led by University Hospital, Antwerp · Updated on 2024-06-14
270
Participants Needed
19
Research Sites
561 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)).
CONDITIONS
Official Title
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Written informed consent prior to any study-related procedures
- Eastern Cooperative Oncology Group (ECOG) performance status 652
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
AZ Klina
Brasschaat, Antwerp, Belgium
Actively Recruiting
2
AZ Rivierenland
Rumst, Antwerp, Belgium
Active, Not Recruiting
3
Ghent University Hospital
Ghent, East Flanders, Belgium
Active, Not Recruiting
4
VITAZ
Sint-Niklaas, East-Flanders, Belgium
Actively Recruiting
5
University Hospital Leuven
Leuven, Flemish Brabant, Belgium
Actively Recruiting
6
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
Active, Not Recruiting
7
AZ Monica
Antwerp, Belgium
Not Yet Recruiting
8
GZA
Antwerp, Belgium
Active, Not Recruiting
9
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Withdrawn
10
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
11
H.U.B.
Brussels, Belgium
Active, Not Recruiting
12
Antwerp University Hospital
Edegem, Belgium
Actively Recruiting
13
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium
Active, Not Recruiting
14
Rijnstate
Arnhem, Gelderland, Netherlands
Actively Recruiting
15
Maastricht UMC+
Maastricht, Limburg, Netherlands
Actively Recruiting
16
Maxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
Active, Not Recruiting
17
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Active, Not Recruiting
18
UMC Groningen
Groningen, Netherlands
Actively Recruiting
19
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
Research Team
M
Marc U Peeters, MD
CONTACT
T
Timon Vandamme, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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