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Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

NCT05701241 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2024-06-14

No results posted yet for this study

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

DRUG

Somatostatin analog

Somatostatin analog treatment every 4 weeks

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Belgium Health Care Knowledge Centre

    collaborator OTHER_GOV

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Marc Peeters, MD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2029-04-30
Completion
2034-04-30
FDA Drug
Yes

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701241 on ClinicalTrials.gov