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Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients (SAUNA)

Primary Purpose

Gastroenteropancreatic Neuroendocrine Tumor

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Somatostatin analog
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteropancreatic Neuroendocrine Tumor focused on measuring somatostatin analogues, neuroendocrine tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 baseline, 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

Sites / Locations

  • AZ Klina
  • AZ Rivierenland
  • Ghent University Hospital
  • VITAZ
  • University Hospital Leuven
  • Grand Hôpital de Charleroi
  • AZ Monica
  • Ziekenhuis Netwerk Antwerpen
  • GZA
  • H.U.B.
  • Cliniques Universitaires Saint-Luc
  • Antwerp University HospitalRecruiting
  • Centre Hospitalier Universitaire Sart Tilman
  • AZ Voorkempen
  • Rijstate
  • Maastricht UMC+
  • Maxima Medisch Centrum
  • Amsterdam UMC
  • UMC Groningen
  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

somatostatin analogs continuation

somatostatin analogs withdrawal

Arm Description

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.

Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

progression-free survival rate according to RECIST 1.1
PFS rate
The difference in a pooled progression-free survival of both substudies
PFS
The difference in a pooled time to deterioration of both substudies
TTD
Overall survival (OS) per substudy and pooled over both substudies
OS
Overall survival pooled over both substudies
OS
Response rates (RR) per substudy
RR
Response rates over both substudies
RR
Quality of life (QoL) measurement with questionnaire
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
Quality of life (QoL) measurement with questionnaire
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
Quality of life (QoL) measurement with questionnaire
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Cost-effectiveness
Health technology assessment (HTA) analysis
Drug safety
Safety will be reported in terms of incidence and severity of (serious) adverse events

Full Information

First Posted
January 5, 2023
Last Updated
July 10, 2023
Sponsor
University Hospital, Antwerp
Collaborators
Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05701241
Brief Title
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients
Acronym
SAUNA
Official Title
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
April 2029 (Anticipated)
Study Completion Date
April 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteropancreatic Neuroendocrine Tumor
Keywords
somatostatin analogues, neuroendocrine tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
somatostatin analogs continuation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
somatostatin analogs withdrawal
Arm Type
No Intervention
Arm Description
Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.
Intervention Type
Drug
Intervention Name(s)
Somatostatin analog
Other Intervention Name(s)
lanreotide, octreotide, sandostatin, somatuline
Intervention Description
Somatostatin analog treatment every 4 weeks
Primary Outcome Measure Information:
Title
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
Description
PFS
Time Frame
18 months after start second-line treatment
Title
The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy
Description
TTD
Time Frame
18 months after start second-line treatment
Secondary Outcome Measure Information:
Title
progression-free survival rate according to RECIST 1.1
Description
PFS rate
Time Frame
18 months after start second-line treatment
Title
The difference in a pooled progression-free survival of both substudies
Description
PFS
Time Frame
18 months after start second-line treatment
Title
The difference in a pooled time to deterioration of both substudies
Description
TTD
Time Frame
18 months after start second-line treatment
Title
Overall survival (OS) per substudy and pooled over both substudies
Description
OS
Time Frame
Time until death; assessed up to 5 years after treatment phase
Title
Overall survival pooled over both substudies
Description
OS
Time Frame
Time until death; assessed up to 5 years after treatment phase
Title
Response rates (RR) per substudy
Description
RR
Time Frame
18 months after start second-line treatment
Title
Response rates over both substudies
Description
RR
Time Frame
18 months after start second-line treatment
Title
Quality of life (QoL) measurement with questionnaire
Description
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
Time Frame
End of study (6.5 years after start second-line treatment)
Title
Quality of life (QoL) measurement with questionnaire
Description
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
Time Frame
End of study (6.5 years after start second-line treatment)
Title
Quality of life (QoL) measurement with questionnaire
Description
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
Time Frame
End of study (6.5 years after start second-line treatment)
Title
Cost-effectiveness
Description
Health technology assessment (HTA) analysis
Time Frame
End of study (6.5 years after start second-line treatment)
Title
Drug safety
Description
Safety will be reported in terms of incidence and severity of (serious) adverse events
Time Frame
18 months after start second-line treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 baseline, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc U Peeters, MD
Phone
03821
Ext
4366
Email
sauna@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Timon Vandamme, MD
Email
timon.vandamme@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Peeters, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Klina
City
Brasschaat
State/Province
Antwerp
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Demey
Facility Name
AZ Rivierenland
City
Rumst
State/Province
Antwerp
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marijke Ulenaers
Facility Name
Ghent University Hospital
City
Ghent
State/Province
East Flanders
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Geboes
Facility Name
VITAZ
City
Sint-Niklaas
State/Province
East-Flanders
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willem Lybaert
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Flemish Brabant
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Verslype
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Sinapi
Facility Name
AZ Monica
City
Antwerpen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timon Vandamme
Facility Name
Ziekenhuis Netwerk Antwerpen
City
Antwerpen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Van Fraeyenhove
Facility Name
GZA
City
Antwerp
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Maurissen
Facility Name
H.U.B.
City
Brussels
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Karfis
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Borbath
Facility Name
Antwerp University Hospital
City
Edegem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timon Vandamme
Email
sauna@uza.be
Facility Name
Centre Hospitalier Universitaire Sart Tilman
City
Liège
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Lousberg
Facility Name
AZ Voorkempen
City
Malle
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Demey
Facility Name
Rijstate
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theo Van Voorthuizen
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loes Latten-Jansen
Facility Name
Maxima Medisch Centrum
City
Eindhoven
State/Province
North Brabant
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Dercksen
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
North Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Klumpen
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemiek Walenkamp
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter de Herder

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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