Current partner codePEPTIDESDE
NCT05701241·Phase 4·INTERVENTIONAL

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Status

Recruiting

Phase

Phase 4

Enrollment

270

Locations

19

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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)).

Interventions

Treatment arms and agents.

DRUG

Somatostatin analog

Somatostatin analog treatment every 4 weeks

Timeline

From registration to results.

  1. First posted

    Jan 27, 2023

  2. Study start

    Jun 28, 2023

  3. Primary completion

    Apr 2029

  4. Study completion

    Apr 2034

  5. Results posted

    Not reported

  6. Registry updated

    Jun 14, 2024

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 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

Time frame · 18 months after start second-line treatment

TTD

Secondary outcomes

progression-free survival rate according to RECIST 1.1

Time frame · 18 months after start second-line treatment

PFS rate

The difference in a pooled progression-free survival of both substudies

Time frame · 18 months after start second-line treatment

PFS

The difference in a pooled time to deterioration of both substudies

Time frame · 18 months after start second-line treatment

TTD

Overall survival (OS) per substudy and pooled over both substudies

Time frame · Time until death; assessed up to 5 years after treatment phase

OS

Overall survival pooled over both substudies

Time frame · Time until death; assessed up to 5 years after treatment phase

OS

Response rates (RR) per substudy

Time frame · 18 months after start second-line treatment

RR

Response rates over both substudies

Time frame · 18 months after start second-line treatment

RR

Quality of life (QoL) measurement with questionnaire

Time frame · End of study (6.5 years after start second-line treatment)

QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)

Quality of life (QoL) measurement with questionnaire

Time frame · End of study (6.5 years after start second-line treatment)

QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)

Quality of life (QoL) measurement with questionnaire

Time frame · End of study (6.5 years after start second-line treatment)

QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

19 registered sites.

Belgium · Netherlands. Showing up to 24 locations stored in the fast local snapshot.

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

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