Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

— SAUNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701241
• Other study ID #: EDGE 002337
• Status: Recruiting
• Phase: Phase 4
• Start date: June 28, 2023
• Est. completion date: April 2034

Study information

• Verified date: January 2023
• Source: University Hospital, Antwerp
• Contact: Marc U Peeters, MD
• Phone: 03821
• Email: sauna[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: April 2034
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• 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 baseline, 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

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Somatostatin analog
Somatostatin analog treatment every 4 weeks

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Belgium Health Care Knowledge Centre, Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS	18 months after start second-line treatment
Primary	The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy	TTD	18 months after start second-line treatment
Secondary	progression-free survival rate according to RECIST 1.1	PFS rate	18 months after start second-line treatment
Secondary	The difference in a pooled progression-free survival of both substudies	PFS	18 months after start second-line treatment
Secondary	The difference in a pooled time to deterioration of both substudies	TTD	18 months after start second-line treatment
Secondary	Overall survival (OS) per substudy and pooled over both substudies	OS	Time until death; assessed up to 5 years after treatment phase
Secondary	Overall survival pooled over both substudies	OS	Time until death; assessed up to 5 years after treatment phase
Secondary	Response rates (RR) per substudy	RR	18 months after start second-line treatment
Secondary	Response rates over both substudies	RR	18 months after start second-line treatment
Secondary	Quality of life (QoL) measurement with questionnaire	QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)	End of study (6.5 years after start second-line treatment)
Secondary	Quality of life (QoL) measurement with questionnaire	QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)	End of study (6.5 years after start second-line treatment)
Secondary	Quality of life (QoL) measurement with questionnaire	QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire	End of study (6.5 years after start second-line treatment)
Secondary	Cost-effectiveness	Health technology assessment (HTA) analysis	End of study (6.5 years after start second-line treatment)
Secondary	Drug safety	Safety will be reported in terms of incidence and severity of (serious) adverse events	18 months after start second-line treatment