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NCT Number: NCT05701241

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

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)).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Klina, Brasschaat, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatostatin analog

Drug

Somatostatin analog treatment every 4 weeks

Other names: lanreotide, octreotide, sandostatin, somatuline

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. progression-free survival rate according to RECIST 1.1

    Time frame: 18 months after start second-line treatment

    PFS rate

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

    Time frame: 18 months after start second-line treatment

    PFS

  3. The difference in a pooled time to deterioration of both substudies

    Time frame: 18 months after start second-line treatment

    TTD

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

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

    OS

  5. Overall survival pooled over both substudies

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

    OS

  6. Response rates (RR) per substudy

    Time frame: 18 months after start second-line treatment

    RR

  7. Response rates over both substudies

    Time frame: 18 months after start second-line treatment

    RR

  8. 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)

  9. 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)

  10. 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

  11. Cost-effectiveness

    Time frame: End of study (6.5 years after start second-line treatment)

    Health technology assessment (HTA) analysis

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marc U Peeters, MD

CONTACT

[email protected]

03821 ext. 4366

Timon Vandamme, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Belgium Health Care Knowledge Centre
  • Erasmus Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: SAUNA

Important dates

Study start
2023
Primary completion
2029
Study completion
2034
First posted
Jan 27, 2023
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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