Evidence map›Paper›PMID 40615151›Full record

ArticleBMJ open2025

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

Siddharth Chhajlani, Jelka Kuiper, Philippe Beutels, Ivan Borbath, Wouter Dercksen, Christophe M Deroose, Stella Heemskerk, Suzanne Polinder, Ella Roelant, Elke Smits and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05701241 (Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05701241 phase4recruitingnot on this map

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial

TypeinterventionalSponsorUniversity Hospital, AntwerpRan2023 to 2034Enrolled270ConditionsGastroenteropancreatic Neuroendocrine TumorArmsSomatostatin analog
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Siddharth Chhajlani *Department of Medical Oncology - NETwerk, University Hospital Antwerp, Edegem, Flanders, Belgium.
Jelka Kuiper *Department of Internal Medicine, Section of Endocrinology, Erasmus MC Cancer Center, Rotterdam, Netherlands.ORCID http://orcid.org/0009-0003-3169-2599
Philippe BeutelsCentre for Health Economics Research and Modelling Infectious Diseases (CHERMID), University of Antwerp, Antwerp, Flanders, Belgium.
Ivan BorbathDepartment of Gastroenterology, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Wouter DercksenDepartment of Internal Medicine, Maxima Medical Centre, Veldhoven, Netherlands.
Christophe M DerooseNuclear Medicine, University Hospitals Leuven, Leuven, Flanders, Belgium.
Stella HeemskerkDepartment of Public Health, Erasmus MC Cancer Center, Rotterdam, Netherlands.
Suzanne PolinderDepartment of Public Health, Erasmus MC Cancer Center, Rotterdam, Netherlands.
Ella RoelantClinical Trial Center (CTC), University Hospital Antwerp, Edegem, Flanders, Belgium.
Elke SmitsClinical Trial Center (CTC), University Hospital Antwerp, Edegem, Flanders, Belgium.ORCID http://orcid.org/0000-0002-8129-2193
Iris VerhaegenClinical Trial Center (CTC), University Hospital Antwerp, Edegem, Flanders, Belgium.
Isolde Van der MassenDepartment of Medical Oncology - NETwerk, University Hospital Antwerp, Edegem, Flanders, Belgium.
Annemiek WalenkampDepartment of Medical Oncology, University Medical Centre Groningen, Groningen, Netherlands.
Wouter W de HerderDepartment of Internal Medicine, Section of Endocrinology, Erasmus MC Cancer Center, Rotterdam, Netherlands.ORCID http://orcid.org/0000-0003-1463-5165
Marc PeetersIntegrated Personalized and Precision Oncology Network (IPPON) - Center for Oncological Research (CORE), University of Antwerp, Antwerp, Flanders, Belgium.
Johannes Hofland *Department of Internal Medicine, Section of Endocrinology, Erasmus MC Cancer Center, Rotterdam, Netherlands.
Timon Vandamme *Department of Medical Oncology - NETwerk, University Hospital Antwerp, Edegem, Flanders, Belgium timon.vandamme@uza.be.
SAUNA investigators and the Dutch Belgian Neuroendocrine Tumor Society (DBNETS)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGastroenteropancreatic 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. They are used as first-line therapy in patients with advanced GEP NET, but disease control is limited to a median progression-free survival (mPFS) of 14-32 months. Second-line treatment options include targeted therapy (everolimus or sunitinib), or peptide receptor radionuclide therapy (PRRT) with METHODS AND ANALYSIS: 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. Secondary endpoints include the PFS rate at 18 months, the difference in pooled PFS and TTD combining both substudies, overall survival, response rates, QoL, costs, cost-effectiveness and toxicity. The study design was developed in cooperation with the Belgium and Dutch patient organisations. ETHICS AND DISSEMINATION: The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). Both the trial management group and the steering committee will oversee good governance of this trial. Results of the study will be published in peer-reviewed international journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT05701241.

Indexed as

Antineoplastic AgentsIntestinal NeoplasmsNeuroendocrine TumorsPancreatic NeoplasmsSomatostatinStomach NeoplasmsDisease ProgressionEverolimusHumansMulticenter Studies as TopicOctreotidePragmatic Clinical Trials as TopicProgression-Free SurvivalRandomized Controlled Trials as TopicSunitinibAntineoplastic AgentsEverolimusOctreotideSomatostatinSunitinibEndocrine tumoursGastrointestinal tumoursNUCLEAR MEDICINERandomized Controlled Trial

Identifiers

PMID40615151
PMCPMC12226938

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.