NCT05701241

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)).

Conditions

• Gastroenteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Somatostatin analog	Somatostatin analog treatment every 4 weeks

Timeline

• Start date: 2023-06-28
• Primary completion: 2029-04-01
• Completion: 2034-04-01
• First posted: 2023-01-27
• Last updated: 2024-06-14

Locations

19 sites across 2 countries: Belgium, Netherlands

Regulatory

• FDA-regulated drug study