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New treatment option for Gastroenteropancreatic Neuroendocrine Tumor
Official title Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
ClinicalTrials.gov ID: NCT05701241
What this study is testing
What is Somatostatin analog?
Somatostatin analog is an investigational medicine, being studied as a potential treatment for gastroenteropancreatic neuroendocrine tumor.
Also referred to as lanreotide, octreotide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Documented radiological disease progression on first-line SSA treatment at label dose or higher
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
The study team makes the final eligibility decision.
Where it's taking place
- Brasschaat, Antwerp, Belgium
- Rumst, Antwerp, Belgium
- Ghent, East Flanders, Belgium
- Sint-Niklaas, East-Flanders, Belgium
- Leuven, Flemish Brabant, Belgium
- Charleroi, Hainaut, Belgium
- Antwerp, Belgium
- Brussels, Belgium
- Edegem, Belgium
- Liège, Belgium
- Arnhem, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Eindhoven, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Groningen, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brasschaat, Antwerp, Belgium; Rumst, Antwerp, Belgium; Ghent, East Flanders, Belgium; Sint-Niklaas, East-Flanders, Belgium; Leuven, Flemish Brabant, Belgium; Charleroi, Hainaut, Belgium and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.