Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Study Purpose

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)).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05701241
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Antwerp
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marc Peeters, MD
Principal Investigator Affiliation	University Hospital, Antwerp
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium, Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gastroenteropancreatic Neuroendocrine Tumor

Arms & Interventions

Arms

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.

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.

Interventions

Drug: - Somatostatin analog

Somatostatin analog treatment every 4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

AZ Klina, Brasschaat, Antwerp, Belgium

Status

Recruiting

Address

AZ Klina

Brasschaat, Antwerp,

Site Contact

Wim Demey

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