Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

ConditionGastroenteropancreatic Neuroendocrine Tumor

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Antwerp

About this trial

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)).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Somatostatin analog
Drug
Somatostatin analog treatment every 4 weeks

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: somatostatin analogs continuationActive comparator 1 intervention

Group B: somatostatin analogs withdrawalNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

PFS

Time frame