Clinical trial · Interventional
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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)).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatostatin analog | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- somatostatin analogs continuation
- description
- 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.
- interventionNames
- Drug: Somatostatin analog
- type
- NO_INTERVENTION
- label
- somatostatin analogs withdrawal
- description
- Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.
Primary outcomes (2)
- 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
- timeFrame
- 18 months after start second-line treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- 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