Gastroenteropancreatic Neuroendocrine Tumor
Conditions
Keywords
somatostatin analogues, neuroendocrine tumor
Brief summary
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)).
Interventions
Somatostatin analog treatment every 4 weeks
Sponsors
Erasmus Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Belgium Health Care Knowledge Centre
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 18 months after start second-line treatment | PFS |
| The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy | 18 months after start second-line treatment | TTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in a pooled time to deterioration of both substudies | 18 months after start second-line treatment | TTD |
| Overall survival (OS) per substudy and pooled over both substudies | Time until death; assessed up to 5 years after treatment phase | OS |
| Overall survival pooled over both substudies | Time until death; assessed up to 5 years after treatment phase | OS |
| Response rates (RR) per substudy | 18 months after start second-line treatment | RR |
| progression-free survival rate according to RECIST 1.1 | 18 months after start second-line treatment | PFS rate |
| Quality of life (QoL) measurement with questionnaire | End of study (6.5 years after start second-line treatment) | QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30) |
| Cost-effectiveness | End of study (6.5 years after start second-line treatment) | Health technology assessment (HTA) analysis |
| Drug safety | 18 months after start second-line treatment | Safety will be reported in terms of incidence and severity of (serious) adverse events |
| Response rates over both substudies | 18 months after start second-line treatment | RR |
| The difference in a pooled progression-free survival of both substudies | 18 months after start second-line treatment | PFS |
Countries
Belgium, Netherlands
Contacts
Primary ContactMarc U Peeters, MD
Backup ContactTimon Vandamme, MD
Outcome results
None listed