Clinical trial NCT05701241: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Official title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Keywords: somatostatin analogues
neuroendocrine tumor
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Belgium Health Care Knowledge Centre
First posted: 2023-01-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months after start second-line treatment
measure: The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy
timeFrame: 18 months after start second-line treatment
Secondary outcomes:
measure: progression-free survival rate according to RECIST 1.1
timeFrame: 18 months after start second-line treatment
measure: The difference in a pooled progression-free survival of both substudies
timeFrame: 18 months after start second-line treatment
measure: The difference in a pooled time to deterioration of both substudies
timeFrame: 18 months after start second-line treatment
measure: Overall survival (OS) per substudy and pooled over both substudies
timeFrame: Time until death; assessed up to 5 years after treatment phase
measure: Overall survival pooled over both substudies
timeFrame: Time until death; assessed up to 5 years after treatment phase
measure: Response rates (RR) per substudy
timeFrame: 18 months after start second-line treatment
measure: Response rates over both substudies
timeFrame: 18 months after start second-line treatment
measure: Quality of life (QoL) measurement with questionnaire
timeFrame: End of study (6.5 years after start second-line treatment)
measure: Quality of life (QoL) measurement with questionnaire
timeFrame: End of study (6.5 years after start second-line treatment)
measure: Quality of life (QoL) measurement with questionnaire
timeFrame: End of study (6.5 years after start second-line treatment)
measure: Cost-effectiveness
timeFrame: End of study (6.5 years after start second-line treatment)
measure: Drug safety
timeFrame: 18 months after start second-line treatment
Other outcomes:
Locations:
city: Brasschaat
country: Belgium
facility: AZ Klina
state: Antwerp
city: Rumst
country: Belgium
facility: AZ Rivierenland
state: Antwerp
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
city: Sint-Niklaas
country: Belgium
facility: VITAZ
state: East-Flanders
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Flemish Brabant
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Antwerp
country: Belgium
facility: GZA
city: Brussels
country: Belgium
facility: H.U.B.
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman
city: Arnhem
country: Netherlands
facility: Rijnstate
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: North Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: North Holland
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: University Hospital, Antwerp
name: Marc Peeters, MD
role: PRINCIPAL_INVESTIGATOR
References: