Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

NCT05701241 | Recruiting Phase 4 FDA Drug

• 1 other identifier: EDGE 002337
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 19

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)).

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Keywords

somatostatin analogues; neuroendocrine tumor

Outcome Measures

Primary Outcomes (2)

• 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

  18 months after start second-line treatment

• The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy

  TTD

  18 months after start second-line treatment

Secondary Outcomes (12)

• progression-free survival rate according to RECIST 1.1

  18 months after start second-line treatment

• The difference in a pooled progression-free survival of both substudies

  18 months after start second-line treatment

• The difference in a pooled time to deterioration of both substudies

  18 months after start second-line treatment

• Overall survival (OS) per substudy and pooled over both substudies

  Time until death; assessed up to 5 years after treatment phase

• Overall survival pooled over both substudies

  Time until death; assessed up to 5 years after treatment phase

Study Arms (2)

somatostatin analogs continuation

ACTIVE COMPARATOR

Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.

Drug: Somatostatin analog

somatostatin analogs withdrawal

NO INTERVENTION

Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

Interventions

Somatostatin analog DRUG

Somatostatin analog treatment every 4 weeks

Also known as: lanreotide, octreotide, sandostatin, somatuline

somatostatin analogs continuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Erasmus Medical Center: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Belgium Health Care Knowledge Centre: collaborator

Study Sites (19)

AZ Klina

Brasschaat, Antwerp, Belgium

RECRUITING

AZ Rivierenland

Rumst, Antwerp, Belgium

ACTIVE NOT RECRUITING

Ghent University Hospital

Ghent, East Flanders, Belgium

ACTIVE NOT RECRUITING

VITAZ

Sint-Niklaas, East-Flanders, Belgium

RECRUITING

University Hospital Leuven

Leuven, Flemish Brabant, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

ACTIVE NOT RECRUITING

AZ Monica

Antwerp, Belgium

NOT YET RECRUITING

GZA

Antwerp, Belgium

ACTIVE NOT RECRUITING

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

WITHDRAWN

Cliniques Universitaires Saint-Luc

Brussels, Belgium

RECRUITING

H.U.B.

Brussels, Belgium

ACTIVE NOT RECRUITING

Antwerp University Hospital

Edegem, Belgium

RECRUITING

Centre Hospitalier Universitaire Sart Tilman

Liège, Belgium

ACTIVE NOT RECRUITING

Rijnstate

Arnhem, Gelderland, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Limburg, Netherlands

RECRUITING

Maxima Medisch Centrum

Eindhoven, North Brabant, Netherlands

ACTIVE NOT RECRUITING

Amsterdam UMC

Amsterdam, North Holland, Netherlands

ACTIVE NOT RECRUITING

UMC Groningen

Groningen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Related Publications (1)

• Chhajlani S, Kuiper J, Beutels P, Borbath I, Dercksen W, Deroose CM, Heemskerk S, Polinder S, Roelant E, Smits E, Verhaegen I, Van der Massen I, Walenkamp A, de Herder WW, Peeters M, Hofland J, Vandamme T; SAUNA investigators and the Dutch Belgian Neuroendocrine Tumor Society (DBNETS). Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol. BMJ Open. 2025 Jul 3;15(7):e099996. doi: 10.1136/bmjopen-2025-099996.

  PMID: 40615151 DERIVED

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Neuroendocrine Tumors

Interventions

Somatostatin; lanreotide; Octreotide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Marc Peeters, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc U Peeters, MD

CONTACT

03821; sauna@uza.be

Timon Vandamme, MD

CONTACT

timon.vandamme@uza.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 27, 2023
• Study Start: June 28, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2034
• Last Updated: June 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6); BE (13)