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Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients (SAUNA trial)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502703-30-00
Acronym
SAUNA
Enrollment
270
Registered
2023-05-31
Start date
2023-06-28
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroendocrine tumours

Brief summary

The difference in PFS between patients continuing or stopping SSA after initiating PRRT, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework., The difference in PFS between patients continuing or stopping SSA after initiating targeted therapy, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework., The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating PRRT., The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating targeted therapy.

Detailed description

PFS rate according to RECIST 1.1 at 18 months per substudy, The difference in pooled PFS and TTD of both substudies, Overall survival per substudy and pooled over both substudies, Response rates per substudy and pooled over both substudies, Quality of life (QoL), Cost-effectiveness, Toxicity

Interventions

DRUGOCTREOTIDE
DRUGEVEROLIMUS
DRUGLANREOTIDE
DRUGSUNITINIB

Sponsors

Antwerp University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The difference in PFS between patients continuing or stopping SSA after initiating PRRT, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework., The difference in PFS between patients continuing or stopping SSA after initiating targeted therapy, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework., The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating PRRT., The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating targeted therapy.

Secondary

MeasureTime frame
PFS rate according to RECIST 1.1 at 18 months per substudy, The difference in pooled PFS and TTD of both substudies, Overall survival per substudy and pooled over both substudies, Response rates per substudy and pooled over both substudies, Quality of life (QoL), Cost-effectiveness, Toxicity

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026