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RECRUITINGPhase 4INTERVENTIONAL

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)).

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - Written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

DRUG

Somatostatin analog

Somatostatin analog treatment every 4 weeks

Locations (19)

AZ Klina
Brasschaat, Antwerp, Belgium
AZ Rivierenland
Rumst, Antwerp, Belgium
Ghent University Hospital
Ghent, East Flanders, Belgium
VITAZ
Sint-Niklaas, East-Flanders, Belgium
University Hospital Leuven
Leuven, Flemish Brabant, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
AZ Monica
Antwerp, Belgium
GZA
Antwerp, Belgium
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
H.U.B.
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium
Rijnstate
Arnhem, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Maxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
UMC Groningen
Groningen, Netherlands
Erasmus MC
Rotterdam, Netherlands