Trial Title:
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
NCT ID:
NCT05701241
Condition:
Gastroenteropancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Octreotide
Lanreotide
Somatostatin
Conditions: Keywords:
somatostatin analogues
neuroendocrine tumor
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Somatostatin analog
Description:
Somatostatin analog treatment every 4 weeks
Arm group label:
somatostatin analogs continuation
Other name:
lanreotide
Other name:
octreotide
Other name:
sandostatin
Other name:
somatuline
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)).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AZ Klina
Address:
City:
Brasschaat
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Wim Demey
Facility:
Name:
AZ Rivierenland
Address:
City:
Rumst
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Ghent University Hospital
Address:
City:
Ghent
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
VITAZ
Address:
City:
Sint-Niklaas
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Willem Lybaert
Facility:
Name:
University Hospital Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Chris Verslype
Facility:
Name:
Grand Hôpital de Charleroi
Address:
City:
Charleroi
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
AZ Monica
Address:
City:
Antwerpen
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Luc Poelmans
Facility:
Name:
Ziekenhuis Netwerk Antwerpen
Address:
City:
Antwerpen
Country:
Belgium
Status:
Withdrawn
Facility:
Name:
GZA
Address:
City:
Antwerp
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
H.U.B.
Address:
City:
Brussels
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussel
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ivan Borbath
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Timon Vandamme
Email:
sauna@uza.be
Facility:
Name:
Centre Hospitalier Universitaire Sart Tilman
Address:
City:
Liège
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Rijnstate
Address:
City:
Arnhem
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Theo Van Voorthuizen
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Loes Latten-Jansen
Facility:
Name:
Maxima Medisch Centrum
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Annemiek Walenkamp
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Hans Hofland
Start date:
June 28, 2023
Completion date:
April 2034
Lead sponsor:
Agency:
University Hospital, Antwerp
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Collaborator:
Agency:
Belgium Health Care Knowledge Centre
Agency class:
Other
Source:
University Hospital, Antwerp
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701241
