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Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Study acronym: SAUNA
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Study sites: 20 to 19
    • Eligibility criteria expanded, about 5 words
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2023 to Jun 28, 2023
    • Site details revised at 20 of 20 sites
    v3
  3. Study sites: 18 to 20v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)).
Trial Details
NCT Number NCT05701241
Lead Sponsor University Hospital, Antwerp
Collaborators: Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre
Conditions
(from sponsor)		 Gastroenteropancreatic Neuroendocrine Tumor
Related terms Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov