Continuing somatostatin analogues for patients with advanced neuroendocrine tumors

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

This study is testing whether continuing somatostatin therapy helps people with advanced neuroendocrine tumors do better after their initial treatment compared to stopping the therapy when they start a new treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Antwerp (other)
• Drugs / interventions: sunitinib, chemotherapy
• Locations: 19 sites (Brasschaat, Antwerp and 18 other locations)
• Trial ID: NCT05701241 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of continuing somatostatin analogues in patients with advanced gastroenteropancreatic neuroendocrine tumors who show disease progression after initial treatment. Participants will be randomly assigned to either continue or stop somatostatin analogue therapy when starting second-line treatment, which may include peptide receptor radionuclide therapy or targeted therapy. The study aims to determine the impact of this decision on patient outcomes, with stratification based on tumor characteristics and treatment site.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, non-functional gastroenteropancreatic neuroendocrine tumors who have shown disease progression on first-line somatostatin analogue therapy.

Not a fit: Patients with poorly differentiated neuroendocrine carcinoma or those requiring chemotherapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for patients with advanced neuroendocrine tumors, potentially leading to better disease management.

How similar studies have performed: Other studies have explored the use of somatostatin analogues in neuroendocrine tumors, but this specific approach of continuing therapy upon progression is novel.

Eligibility criteria

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

Where this trial is running

Brasschaat, Antwerp and 18 other locations

• AZ Klina — Brasschaat, Antwerp, Belgium (RECRUITING)
• AZ Rivierenland — Rumst, Antwerp, Belgium (ACTIVE_NOT_RECRUITING)
• Ghent University Hospital — Ghent, East Flanders, Belgium (ACTIVE_NOT_RECRUITING)
• VITAZ — Sint-Niklaas, East-Flanders, Belgium (RECRUITING)
• University Hospital Leuven — Leuven, Flemish Brabant, Belgium (RECRUITING)
• Grand Hôpital de Charleroi — Charleroi, Hainaut, Belgium (ACTIVE_NOT_RECRUITING)
• AZ Monica — Antwerp, Belgium (NOT_YET_RECRUITING)
• GZA — Antwerp, Belgium (ACTIVE_NOT_RECRUITING)
• Ziekenhuis Netwerk Antwerpen — Antwerp, Belgium (WITHDRAWN)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium (RECRUITING)
• H.U.B. — Brussels, Belgium (ACTIVE_NOT_RECRUITING)
• Antwerp University Hospital — Edegem, Belgium (RECRUITING)
• Centre Hospitalier Universitaire Sart Tilman — Liège, Belgium (ACTIVE_NOT_RECRUITING)
• Rijnstate — Arnhem, Gelderland, Netherlands (RECRUITING)
• Maastricht UMC+ — Maastricht, Limburg, Netherlands (RECRUITING)
• Maxima Medisch Centrum — Eindhoven, North Brabant, Netherlands (ACTIVE_NOT_RECRUITING)
• Amsterdam UMC — Amsterdam, North Holland, Netherlands (ACTIVE_NOT_RECRUITING)
• UMC Groningen — Groningen, Netherlands (RECRUITING)
• Erasmus MC — Rotterdam, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Marc Peeters, MD — University Hospital, Antwerp
• Study coordinator: Marc U Peeters, MD

Conditions: Gastroenteropancreatic Neuroendocrine Tumor, somatostatin analogues, neuroendocrine tumor