Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Официальное название

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

Обзор

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)).

Вмешательства

• Препарат Somatostatin analog
  Somatostatin analog treatment every 4 weeks

Первичные конечные точки

• 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 [Срок оценки: 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 [Срок оценки: 18 months after start second-line treatment]

Вторичные конечные точки (12)

• progression-free survival rate according to RECIST 1.1 [Срок оценки: 18 months after start second-line treatment]
• The difference in a pooled progression-free survival of both substudies [Срок оценки: 18 months after start second-line treatment]
• The difference in a pooled time to deterioration of both substudies [Срок оценки: 18 months after start second-line treatment]
• Overall survival (OS) per substudy and pooled over both substudies [Срок оценки: Time until death; assessed up to 5 years after treatment phase]
• Overall survival pooled over both substudies [Срок оценки: Time until death; assessed up to 5 years after treatment phase]
• Response rates (RR) per substudy [Срок оценки: 18 months after start second-line treatment]
• Response rates over both substudies [Срок оценки: 18 months after start second-line treatment]
• Quality of life (QoL) measurement with questionnaire [Срок оценки: End of study (6.5 years after start second-line treatment)]
• Quality of life (QoL) measurement with questionnaire [Срок оценки: End of study (6.5 years after start second-line treatment)]
• Quality of life (QoL) measurement with questionnaire [Срок оценки: End of study (6.5 years after start second-line treatment)]
• Cost-effectiveness [Срок оценки: End of study (6.5 years after start second-line treatment)]
• Drug safety [Срок оценки: 18 months after start second-line treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 13 центров

• AZ Klina — Brasschaat
• AZ Rivierenland — Rumst
• Ghent University Hospital — Ghent
• VITAZ — Sint-Niklaas
• University Hospital Leuven — Leuven
• Grand Hôpital de Charleroi — Charleroi
• AZ Monica — Antwerp
• GZA — Antwerp
• … и ещё 5 центров

Нидерланды · 6 центров

• Rijnstate — Arnhem
• Maastricht UMC+ — Maastricht
• Maxima Medisch Centrum — Eindhoven
• Amsterdam UMC — Amsterdam
• UMC Groningen — Groningen
• Erasmus MC — Rotterdam

Публикации

• Chhajlani S, Kuiper J, Beutels P, Borbath I, Dercksen W, Deroose CM, Heemskerk S, Polinder S, Roelant E, Smits E, Verhaegen I, Van der Massen I, Walenkamp A, de Herder WW, Peeters M, Hofland J, Vandamme T; SAUNA investigators and the Dutch Belgian Neuroendocrine Tumor Society (DBNETS). Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour PMID 40615151

Идентификаторы

NCT: NCT05701241 · EDGE 002337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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