SAUNA

Studie-informatie

Introductie en rationale

Advanced gastroenteropancreatic neuroendocrine tumors (GEP NET) are treated with targeted therapy or peptide receptor radionuclide therapy (PRRT) (177Lu-DOTATATE) upon progression under somatostatin analogues (SSA). SSA are continued life-long in functional NET, but the benefit of SSA continuation in non-functional NET is unclear. Due to ongoing activity of the somatostatin receptor pathway in GEP NET progressing on SSA, we hypothesize an added efficacy of SSA during second-line therapy. The aim is to study the efficacy of SSA continuation during second-line therapy in advanced GEP NET.

Methodologie

The SAUNA trial (clinicaltrials.gov.: NCT05701241) is a bi-national, multi-center (19 sites), open-label, randomized, pragmatic clinical trial. 270 patients with advanced, non-functional grade 1-2 GEP NET progressing on SSA will be divided into study arm 1 (PRRT; n=142) or study arm 2 [targeted therapy (everolimus/sunitinib); n=128] per investigator’s choice of second-line therapy, and randomized (1:1) per study arm between SSA continuation or withdrawal. Coprimary endpoints are improvement in progression-free survival (PFS) and in time to deterioration (TTD) of quality of life (QoL) per EORTC-QLQC30 questionnaire per study arm with a hazard ratio of 0.54 and 0.55, respectively. Secondary endpoints include PFS at 18 months, pooled PFS- and TTD-analyses, overall survival, response rates, QoL, medical costs, cost-effectiveness, and toxicity. Study received ethical committee approval (31/05/2023) and recruitment is ongoing. This is an independent trial funded by BeNeFIT (21577).

Resultaten (trial in progress)

• The trial is poised to provide high-grade evidence regarding efficacy of SSA continuation during second-line therapy in terms of PFS, QoL, and cost effectiveness.
  

Status

• Open voor inclusies
• Zie up-to-date inclusie status op op studie-website

Contact

• email: sauna@uza.be / saunastudie@erasmusmc.nl
• website: https://saunatrial.eu/