Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Short name SAUNA

NCTNCT05701241Other idEDGE 002337

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 270 participants (estimated)
Sponsor: University Hospital, Antwerp · Other
Design: Randomized · Open label (no masking)
Countries: 2 countries
Belgium, Netherlands
Start: 28 Jun 2023
Primary completion: Apr 2029 (estimated)
Completion: Apr 2034 (estimated)
First posted: 27 Jan 2023
Last update posted: 14 Jun 2024
Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420262028203020322034

Ph 4
SAUNA
NCT05701241
28 Jun 2023 to est. Apr 2034

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)).

Interventions

Somatostatin analogDrug

Arms2

Active comparator
somatostatin analogs continuation
Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.
No intervention
somatostatin analogs withdrawal
Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

Primary outcomes2

Outcomes the sponsor listed as primary.

the difference in progression-free survival (PFS) in patients continuing or stopping second-line therapy with SSAs, as assessed by the blinded local investigator on cross-sectional imaging, according to RECIST 1.1 criteria per substudy
Time frame · 18 months after start second-line treatment
Registry description
PFS
The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy
Time frame · 18 months after start second-line treatment
Registry description
TTD

Secondary outcomes(12)

progression-free survival rate according to RECIST 1.1
Time frame · 18 months after start second-line treatment
Registry description
PFS rate
The difference in a pooled progression-free survival of both substudies
Time frame · 18 months after start second-line treatment
Registry description
PFS
The difference in a pooled time to deterioration of both substudies
Time frame · 18 months after start second-line treatment
Registry description
TTD
Overall survival (OS) per substudy and pooled over both substudies
Time frame · Time until death; assessed up to 5 years after treatment phase
Registry description
OS
Overall survival pooled over both substudies
Time frame · Time until death; assessed up to 5 years after treatment phase
Registry description
OS
Response rates (RR) per substudy
Time frame · 18 months after start second-line treatment
Registry description
RR
Response rates over both substudies
Time frame · 18 months after start second-line treatment
Registry description
RR
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
Registry description
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
Registry description
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
Quality of life (QoL) measurement with questionnaire
Time frame · End of study (6.5 years after start second-line treatment)
Registry description
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Cost-effectiveness
Time frame · End of study (6.5 years after start second-line treatment)
Registry description
Health technology assessment (HTA) analysis
Drug safety
Time frame · 18 months after start second-line treatment
Registry description
Safety will be reported in terms of incidence and severity of (serious) adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedChhajlani S, Kuiper J, Beutels P, Borbath I, Dercksen W, Deroose CM, Heemskerk S, Polinder S, Roelant E, Smits E, Verhaegen I, Van der Massen I, Walenkamp A, de Herder WW, Peeters M, Hofland J, Vandamme T; SAUNA investigators and the Dutch Belgian Neuroendocrine Tumor Society (DBNETS). Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol. BMJ Open. 2025 Jul 3;15(7):e099996. doi: 10.1136/bmjopen-2025-099996. PMID 40615151

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age ≥18 years * Written informed consent prior to any study-related procedures * Eastern Cooperative Oncology Group (ECOG) performance status ≤2, * Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET * Documented radiological disease progression on first-line SSA treatment at label dose or higher * For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator * For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator Exclusion Criteria: * Indication for chemotherapy treatment of GEP NET in second-line * Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET * Prior treatment with everolimus, sunitinib or PRRT * Contra-indication, proven allergy or other indication than functional NET for the use of a SSA * Patient showing progressive disease while being on a lower than the registered dose * Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome * Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET * Concurrent anti-cancer treatment in another investigational trial * Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study * Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial

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