Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Launched by UNIVERSITY HOSPITAL, ANTWERP · Jan 17, 2023

Keywords

ClinConnect Summary

The SAUNA trial is studying the best approach for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP NET) who are experiencing disease progression after their initial treatment with somatostatin analogues (SSA). This trial is looking to find out whether continuing SSA alongside new treatments will help patients more than stopping SSA when they begin a second-line therapy, which could be either peptide receptor radionuclide therapy (PRRT) or targeted therapy. Patients will be randomly assigned to either continue or stop SSA as they start their new treatment.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of advanced GEP NET, and show evidence that their disease has progressed while on SSA treatment. They also need to have a certain level of performance and be able to provide written consent. Throughout the trial, participants will have regular check-ins to monitor their health and response to treatment. This trial is important because it may help determine the most effective treatment strategy for patients with this type of cancer.

Gender

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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