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

June 13, 2024 updated by: University Hospital, Antwerp

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

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)).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marc U Peeters, MD
  • Phone Number: 4366 03821
  • Email: sauna@uza.be

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Active, not recruiting
        • GZA
      • Antwerpen, Belgium
        • Not yet recruiting
        • AZ Monica
        • Contact:
          • Luc Poelmans
      • Antwerpen, Belgium
        • Withdrawn
        • Ziekenhuis Netwerk Antwerpen
      • Brussel, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Ivan Borbath
      • Brussels, Belgium
        • Active, not recruiting
        • H.U.B.
      • Edegem, Belgium
        • Recruiting
        • Antwerp University Hospital
        • Contact:
      • Liège, Belgium
        • Active, not recruiting
        • Centre Hospitalier Universitaire Sart Tilman
    • Antwerp
      • Brasschaat, Antwerp, Belgium
        • Recruiting
        • AZ Klina
        • Contact:
          • Wim Demey
      • Rumst, Antwerp, Belgium
        • Active, not recruiting
        • AZ Rivierenland
    • East Flanders
      • Ghent, East Flanders, Belgium
        • Active, not recruiting
        • Ghent University Hospital
    • East-Flanders
      • Sint-Niklaas, East-Flanders, Belgium
        • Recruiting
        • Vitaz
        • Contact:
          • Willem Lybaert
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium
        • Recruiting
        • University Hospital Leuven
        • Contact:
          • Chris Verslype
    • Hainaut
      • Charleroi, Hainaut, Belgium
        • Active, not recruiting
        • Grand Hopital de Charleroi
  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • UMC Groningen
        • Contact:
          • Annemiek Walenkamp
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
        • Contact:
          • Hans Hofland
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Recruiting
        • Rijnstate
        • Contact:
          • Theo Van Voorthuizen
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Loes Latten-Jansen
    • North Brabant
      • Eindhoven, North Brabant, Netherlands
        • Active, not recruiting
        • Maxima Medisch Centrum
    • North Holland
      • Amsterdam, North Holland, Netherlands
        • Active, not recruiting
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: somatostatin analogs continuation
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 analog treatment every 4 weeks
Other Names:
  • somatuline
  • sandostatin
  • lanreotide
  • octreotide
No Intervention: somatostatin analogs withdrawal
Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 18 months after start second-line treatment
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
Time Frame: 18 months after start second-line treatment
TTD
18 months after start second-line treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
progression-free survival rate according to RECIST 1.1
Time Frame: 18 months after start second-line treatment
PFS rate
18 months after start second-line treatment
The difference in a pooled progression-free survival of both substudies
Time Frame: 18 months after start second-line treatment
PFS
18 months after start second-line treatment
The difference in a pooled time to deterioration of both substudies
Time Frame: 18 months after start second-line treatment
TTD
18 months after start second-line treatment
Overall survival (OS) per substudy and pooled over both substudies
Time Frame: Time until death; assessed up to 5 years after treatment phase
OS
Time until death; assessed up to 5 years after treatment phase
Overall survival pooled over both substudies
Time Frame: Time until death; assessed up to 5 years after treatment phase
OS
Time until death; assessed up to 5 years after treatment phase
Response rates (RR) per substudy
Time Frame: 18 months after start second-line treatment
RR
18 months after start second-line treatment
Response rates over both substudies
Time Frame: 18 months after start second-line treatment
RR
18 months after start second-line treatment
Quality of life (QoL) measurement with questionnaire
Time Frame: End of study (6.5 years after start second-line treatment)
QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)
End of study (6.5 years after start second-line treatment)
Quality of life (QoL) measurement with questionnaire
Time Frame: End of study (6.5 years after start second-line treatment)
QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)
End of study (6.5 years after start second-line treatment)
Quality of life (QoL) measurement with questionnaire
Time Frame: End of study (6.5 years after start second-line treatment)
QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire
End of study (6.5 years after start second-line treatment)
Cost-effectiveness
Time Frame: End of study (6.5 years after start second-line treatment)
Health technology assessment (HTA) analysis
End of study (6.5 years after start second-line treatment)
Drug safety
Time Frame: 18 months after start second-line treatment
Safety will be reported in terms of incidence and severity of (serious) adverse events
18 months after start second-line treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Erasmus Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Belgium Health Care Knowledge Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Peeters, MD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDGE 002337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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