Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol

What Was Tested

This clinical study looks at Octreotide and Somatostatin.

Gastroenteropancreatic neuroendocrine tumours (GEP NET) are malignant neoplasms that impact survival.

Somatostatin analogues (SSA) are used for treating hormonal symptoms caused by GEP NET and have antiproliferative effects.

Who Took Part

The abstract describes 270 patients taking part.

The SAUNA trial is an international, multicentre, open-label, randomised, controlled, pragmatic clinical trial. 270 patients with advanced, non-functional GEP NET and progression under first-line SSA will be included in substudy 1 (PRRT; n=142) or substudy 2 (targeted therapy (everolimus/sunitinib); n=128) per investigator's choice of second-line therapy and will be randomised (1:1) per substudy between SSA continuation or SSA withdrawal arms.

Co-primary endpoints are the difference in progression-free survival (PFS) according to the RECIST (Response Evaluation Criteria In Solid Tumours) V.1.1 criteria and difference in time to deterioration (TTD) in quality of life (QoL) per substudy after initiating second-line therapy with or without SSA.

How the Study Was Run

In design terms this was a randomized, open-label and multicenter study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the Octreotide study did not mask who received what.

Running at several centres spread the Octreotide study over different clinics and patient groups.

The study design was developed in cooperation with the Belgium and Dutch patient organisations.

What Was Measured

Topics PubMed links to this paper include Neuroendocrine Tumors, Pancreatic Neoplasms, Intestinal Neoplasms, Stomach Neoplasms, Somatostatin, Disease Progression and Everolimus.

The authors tagged it with the keywords Endocrine tumours, Gastrointestinal tumours, NUCLEAR MEDICINE and Randomized Controlled Trial.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Octreotide and Somatostatin in 270 patients.

The publication is from 2025 (BMJ open), a journal based in England.

More context: the Octreotide compound page and the Somatostatin compound page, all human trials.