RecruitingPhase 4NCT05701241

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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


Sponsor

University Hospital, Antwerp

Enrollment

270 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether continuing somatostatin analogues (long-acting hormone-blocking injections used to slow neuroendocrine tumor growth) alongside second-line treatments like everolimus, sunitinib, or PRRT (a targeted radiation therapy) improves outcomes compared to stopping them at disease progression. **You may be eligible if...** - You are 18 or older with a histologically confirmed, slow-growing neuroendocrine tumor of the gastrointestinal or pancreatic type (GEP-NET, grade 1 or 2) - Your tumor is locally advanced or has spread, and it has progressed on first-line somatostatin analogue treatment - You are about to start second-line therapy with everolimus, sunitinib, or PRRT with lutetium **You may NOT be eligible if...** - Your doctor recommends chemotherapy as second-line treatment for your NET - You have a poorly differentiated (high-grade) neuroendocrine carcinoma - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSomatostatin 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

View Full Details on ClinicalTrials.gov

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NCT05701241


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