Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients (SAUNA trial) - SAUNA

Antwerp University Hospital0 个研究点目标入组 270 人开始时间: 2023年2月28日最近更新: 2024年7月22日

适应症

试验速览

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•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 WHO 2019 grade 1-2 GEP NET, Documented radiological disease progression on first-line SSA treatment, 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 177Lu-DOTATATE as second-line therapy, according to local investigator

•Indication for chemotherapy treatment of GEP NET in second-line, Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial, Presence of poorly differentiated grade 3 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 baseline, 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

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