Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 19
- 主要终点
- 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
研究概览
简要总结
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)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Somatostatin analog (Drug)
结局指标
主要结局
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
时间窗: 18 months after start second-line treatment
PFS
The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy
时间窗: 18 months after start second-line treatment
TTD
次要结局
- Overall survival pooled over both substudies(Time until death; assessed up to 5 years after treatment phase)
- Response rates (RR) per substudy(18 months after start second-line treatment)
- Response rates over both substudies(18 months after start second-line treatment)
- Quality of life (QoL) measurement with questionnaire(End of study (6.5 years after start second-line treatment))
- Cost-effectiveness(End of study (6.5 years after start second-line treatment))
- Drug safety(18 months after start second-line treatment)
- Overall survival (OS) per substudy and pooled over both substudies(Time until death; assessed up to 5 years after treatment phase)
- progression-free survival rate according to RECIST 1.1(18 months after start second-line treatment)
- The difference in a pooled progression-free survival of both substudies(18 months after start second-line treatment)
- The difference in a pooled time to deterioration of both substudies(18 months after start second-line treatment)