Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients (NCT05701241) is a Phase 4 interventional studying Gastroenteropancreatic Neuroendocrine Tumor, sponsored by University Hospital, Antwerp. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This 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)).

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 270 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastroenteropancreatic Neuroendocrine Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - Written willing to sign a consent form 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Somatostatin analog

Somatostatin analog treatment every 4 weeks

Locations (19)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

AZ Klina

Brasschaat, Antwerp, Belgium

AZ Rivierenland

Rumst, Antwerp, Belgium

Ghent University Hospital

Ghent, East Flanders, Belgium

VITAZ

Sint-Niklaas, East-Flanders, Belgium

University Hospital Leuven

Leuven, Flemish Brabant, Belgium

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

AZ Monica

Antwerp, Belgium

GZA

Antwerp, Belgium

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

H.U.B.

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

Centre Hospitalier Universitaire Sart Tilman

Liège, Belgium

Rijnstate

Arnhem, Gelderland, Netherlands

Maastricht UMC+

Maastricht, Limburg, Netherlands

Maxima Medisch Centrum

Eindhoven, North Brabant, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

UMC Groningen

Groningen, Netherlands

Erasmus MC

Rotterdam, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05701241), the sponsor (University Hospital, Antwerp), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05701241 clinical trial studying?

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 fro… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05701241?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05701241?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05701241. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05701241. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.