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Gastroenteropancreatic Neuroendocrine TumorPhase 4SAUNANCT05701241

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

A Phase 4 study testing Somatostatin analog in people with Gastroenteropancreatic Neuroendocrine Tumor, run by University Hospital, Antwerp at 19 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Somatostatin analog
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
19 sitesin 2 countries
Study dates
28 Jun 2023to Apr 2034
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Marc U Peeters, MD contact

03821 ext. 4366

sauna@uza.be

Timon Vandamme, MD contact

timon.vandamme@uza.be

19 sites in 2 countries

Belgium13 sites, 6 recruiting

  • AZ Monica

    Antwerp

    Luc Poelmans

    Not yet recruiting

  • GZA

    Antwerp

    Active, not recruiting

  • Ziekenhuis Netwerk Antwerpen

    Antwerp

    Withdrawn

  • AZ Klina

    Brasschaat, Antwerp

    Wim Demey

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels

    Ivan Borbath

    Recruiting

  • H.U.B.

    Brussels

    Active, not recruiting

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut

    Active, not recruiting

  • Antwerp University Hospital

    Edegem

    Timon Vandamme, sauna@uza.be

    Recruiting

  • Ghent University Hospital

    Ghent, East Flanders

    Active, not recruiting

  • University Hospital Leuven

    Leuven, Flemish Brabant

    Chris Verslype

    Recruiting

  • Centre Hospitalier Universitaire Sart Tilman

    Liège

    Active, not recruiting

  • AZ Rivierenland

    Rumst, Antwerp

    Active, not recruiting

  • VITAZ

    Sint-Niklaas, East-Flanders

    Willem Lybaert

    Recruiting

Other trials in Belgium

Netherlands6 sites, 4 recruiting

  • Amsterdam UMC

    Amsterdam, North Holland

    Active, not recruiting

  • Rijnstate

    Arnhem, Gelderland

    Theo Van Voorthuizen

    Recruiting

  • Maxima Medisch Centrum

    Eindhoven, North Brabant

    Active, not recruiting

  • UMC Groningen

    Groningen

    Annemiek Walenkamp

    Recruiting

  • Maastricht UMC+

    Maastricht, Limburg

    Loes Latten-Jansen

    Recruiting

  • Erasmus MC

    Rotterdam

    Hans Hofland

    Recruiting

Other trials in Netherlands

About this study

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

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)).

Being tested
Somatostatin analog
Keywords
somatostatin analogues, neuroendocrine tumor
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Somatostatin analogDrug

    Also called lanreotide, octreotide, sandostatin, somatuline

    Somatostatin analog treatment every 4 weeks

Study groups in NCT05701241
Study groupRoleWhat they receive
somatostatin analogs continuationActive comparatorSomatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.
Receives: Drug: Somatostatin analog
somatostatin analogs withdrawalNo interventionSomatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    PFS

    Measured: 18 months after start second-line treatment

  2. The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy

    TTD

    Measured: 18 months after start second-line treatment

Secondary outcomes (12)

  1. progression-free survival rate according to RECIST 1.1

    PFS rate

    Measured: 18 months after start second-line treatment

  2. The difference in a pooled progression-free survival of both substudies

    PFS

    Measured: 18 months after start second-line treatment

  3. The difference in a pooled time to deterioration of both substudies

    TTD

    Measured: 18 months after start second-line treatment

  4. Overall survival (OS) per substudy and pooled over both substudies

    OS

    Measured: Time until death; assessed up to 5 years after treatment phase

  5. Overall survival pooled over both substudies

    OS

    Measured: Time until death; assessed up to 5 years after treatment phase

  6. Response rates (RR) per substudy

    RR

    Measured: 18 months after start second-line treatment

  7. Response rates over both substudies

    RR

    Measured: 18 months after start second-line treatment

  8. Quality of life (QoL) measurement with questionnaire

    QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)

    Measured: End of study (6.5 years after start second-line treatment)

  9. Quality of life (QoL) measurement with questionnaire

    QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)

    Measured: End of study (6.5 years after start second-line treatment)

  10. Quality of life (QoL) measurement with questionnaire

    QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire

    Measured: End of study (6.5 years after start second-line treatment)

  11. Cost-effectiveness

    Health technology assessment (HTA) analysis

    Measured: End of study (6.5 years after start second-line treatment)

  12. Drug safety

    Safety will be reported in terms of incidence and severity of (serious) adverse events

    Measured: 18 months after start second-line treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start28 Jun 2023
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701241
Sponsor's protocol ID
EDGE 002337
Acronym
SAUNA
Status last verified
Apr 2024
First submitted
5 Jan 2023
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chhajlani 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.

    PubMed 40615151

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Somatostatin analog in people with Gastroenteropancreatic Neuroendocrine Tumor, run by University Hospital, Antwerp at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marc U Peeters, MD (03821 ext. 4366, sauna@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701241, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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