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Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients (SAUNA trial)
EU CTIS ID: 2022-502703-30-00
What this study is testing
First co-primary objective: to assess the difference in progression-free survival (PFS) per substudy between patients continuing or stopping SSA, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 standardised framework after initiating second-line therapy with PRRT (substudy 1) or targeted therapy (substudy 2). Second co-primary objective: to assess the difference in time to deterioration (TTD) after initiating second-line therapy per substudy. TTD is defined as time from randomization to the first decrease from baseline on the Global Health component of the EORTC QLQ-C30 questionnaire by at least 10 points (on an 100-point scale), with no further increase above this threshold, or death.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 WHO 2019 grade 1‒2 GEP NET
- Documented radiological disease progression on first-line SSA treatment
- For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator
You likely can't join if
- Indication for chemotherapy treatment of GEP NET in second-line
- Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
- Presence of poorly differentiated grade 3 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
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 WHO 2019 grade 1‒2 GEP NET
- Documented radiological disease progression on first-line SSA treatment
- 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 177Lu-DOTATATE as second-line therapy, according to local investigator
- Indication for chemotherapy treatment of GEP NET in second-line
- Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
- Presence of poorly differentiated grade 3 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 baseline, 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.