Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05701241

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

Led by University Hospital, Antwerp · Updated on 2024-06-14

270

Participants Needed

19

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

E

Erasmus Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of continuing versus stopping somatostatin analog (SSA) treatment in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumors (NET) who have progressive disease despite first-line SSA therapy. This Phase 4, multi-national, open-label, randomized, controlled trial divides eligible patients into two groups based on their second-line therapy choice: peptide receptor radionuclide therapy (PRRT) or targeted therapy. The study aims to understand the impact of continuing SSA treatment alongside second-line therapies, stratifying patients by tumor grade and study site.

CONDITIONS

Brief Title

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Written informed consent before any study procedures
  • ECOG performance status of 2 or less
  • Histologically confirmed diagnosis of locally advanced or metastatic, non-functional, well-differentiated grade 1-2 GEP neuroendocrine tumor
  • Documented disease progression while on first-line somatostatin analog treatment at label dose or higher
  • For targeted therapy group: planned to start sunitinib or everolimus as second-line treatment
  • For PRRT group: planned to start PRRT with Lutetium (177Lu) oxodotreotide as second-line treatment
Not Eligible

You will not qualify if you...

  • Need for chemotherapy as second-line treatment for GEP NET
  • Presence of poorly differentiated grade 3 neuroendocrine carcinoma or rapidly progressive tumor
  • Previous treatment with everolimus, sunitinib, or PRRT
  • Contraindication or allergy to somatostatin analogs or use for other than functional NET
  • Progressive disease while on lower than registered somatostatin analog dose
  • Functional neuroendocrine tumor with clinical and biochemical syndrome
  • Receiving palliative systemic treatment for other cancers
  • Participation in another investigational anti-cancer trial
  • Any medical or psychiatric condition that could risk patient safety or study data quality
  • Pregnant or breastfeeding, or planning pregnancy during treatment phase

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 months

Participants receive somatostatin analog treatment every 4 weeks or have the treatment withdrawn for 18 months, depending on their assigned group.

Monthly visits for 18 months

Follow-up

Duration - Up to 6.5 years

Participants are followed for overall survival and quality of life assessments up to 6.5 years after starting second-line treatment.

Periodic visits for assessments during follow-up

Trial Site Locations

Total: 19 locations

1

AZ Klina

Brasschaat, Antwerp, Belgium

Actively Recruiting

2

AZ Rivierenland

Rumst, Antwerp, Belgium

Active, Not Recruiting

3

Ghent University Hospital

Ghent, East Flanders, Belgium

Active, Not Recruiting

4

VITAZ

Sint-Niklaas, East-Flanders, Belgium

Actively Recruiting

5

University Hospital Leuven

Leuven, Flemish Brabant, Belgium

Actively Recruiting

6

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

Active, Not Recruiting

7

AZ Monica

Antwerp, Belgium

Not Yet Recruiting

8

GZA

Antwerp, Belgium

Active, Not Recruiting

9

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Withdrawn

10

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Actively Recruiting

11

H.U.B.

Brussels, Belgium

Active, Not Recruiting

12

Antwerp University Hospital

Edegem, Belgium

Actively Recruiting

13

Centre Hospitalier Universitaire Sart Tilman

Liège, Belgium

Active, Not Recruiting

14

Rijnstate

Arnhem, Gelderland, Netherlands

Actively Recruiting

15

Maastricht UMC+

Maastricht, Limburg, Netherlands

Actively Recruiting

16

Maxima Medisch Centrum

Eindhoven, North Brabant, Netherlands

Active, Not Recruiting

17

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Active, Not Recruiting

18

UMC Groningen

Groningen, Netherlands

Actively Recruiting

19

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

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Research Team

M

Marc U Peeters, MD

T

Timon Vandamme, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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

Siddharth Chhajlani, Jelka Kuiper, Philippe Beutels...

https://pubmed.ncbi.nlm.nih.gov/40615151