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NCT05701241 | Recruiting | Gastroenteropancreatic Neuroendocrine Tumor

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Sponsor:

University Hospital, Antwerp

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)).

Condition or disease

Gastroenteropancreatic Neuroendocrine Tumor

Intervention/treatment

Somatostatin analog

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 270 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : April 2029
Estimated Study Completion Date : April 2034
Arm Intervention/treatment

Active Comparator: somatostatin analogs continuation

Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.

No Intervention: somatostatin analogs withdrawal

Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • 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
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Location Details

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Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Belgium, Antwerp

I Klina

Brasschaat, Antwerp, Belgium,

Not yet recruiting

Belgium, Antwerp

AZ Rivierenland

Rumst, Antwerp, Belgium,

Not yet recruiting

Belgium, East Flanders

Ghent University Hospital

Ghent, East Flanders, Belgium,

Not yet recruiting

Belgium, East-Flanders

VITAZ

Sint-Niklaas, East-Flanders, Belgium,

Not yet recruiting

Belgium, Flemish Brabant

University Hospital Leuven

Leuven, Flemish Brabant, Belgium,

Not yet recruiting

Belgium, Hainaut

Grand Hospital of Charleroi

Charleroi, Hainaut, Belgium,

Not yet recruiting

Belgium, Gelderland

That's Monica

Antwerp, Gelderland, Belgium,

Not yet recruiting

Belgium, Limburg

Hospital Network Antwerp

Antwerp, Limburg, Belgium,

Not yet recruiting

Belgium, North Brabant

GZA

Antwerp, North Brabant, Belgium,

Not yet recruiting

Belgium, North Holland

H.U.B.

Brussels, North Holland, Belgium,

Not yet recruiting

Belgium,

Saint-Luc University Clinics

Brussel, Belgium,

Recruiting

Belgium,

Antwerp University Hospital

Edegem, Belgium,

Not yet recruiting

Belgium,

Sart Tilman University Hospital Center

Liège, Belgium,

Not yet recruiting

Belgium,

In Voorkem

Malle, Belgium,

Not yet recruiting

Netherlands,

Rhinestate

Arnhem, Netherlands,

Not yet recruiting

Netherlands,

Maastricht UMC+

Maastricht, Netherlands,

Not yet recruiting

Netherlands,

Maxima Medical Center

Eindhoven, Netherlands,

Not yet recruiting

Netherlands,

Amsterdam UMC

Amsterdam, Netherlands,

Not yet recruiting

Netherlands,

UMC Groningen

Groningen, Netherlands,

Not yet recruiting

Netherlands,

Erasmus MC

Rotterdam, Netherlands,