NCT02788578终止不适用
Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)
研究概览
简要总结
The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Histopathologically confirmed metastatic well differentiated Neuroendocrine Tumour (NET) (Grade G1 or G2 according to the World Health Organisation 2010 classification): Gastro-entero-pancreatic (GEP) or Bronchopulmonary (BP) primary tumour, or tumour of unknown origin believed to be of GEP origin, if a primary tumour elsewhere was excluded by multiphasic computerised tomography (CT) or magnetic resonance imaging (MRI)
- •Disease progression radiologically documented with evaluable imaging (CT or MRI, digital or print-out), performed within 12 months and within 6 months prior to the first PRRT/LAN ATG cycle
- •Metastatic- or locally-advanced, hormonal functioning or nonfunctioning GEP-NET or BP-NET;
- •Confirmed presence of Somatostatin Receptors (SSTRs) on all target lesions based on positive SSTR scintigraphy (Octreoscan®/99mTC-tektrotyd) or 68Ga SSTR Positron Emission Tomography-Computerised Tomography (PET/CT) imaging, i.e. Grade ≥2 respectively per the Krenning scale or per the modified Krenning scale
排除标准
- •Absence of information regarding LAN ATG treatment: dose received, start date, frequency of injections
- •No CT or MRI within 12 months and within 6 months preceding the baseline, or at the end of the last PRRT/LAN ATG cycle
- •Absence of information on cumulative activity of PRRT with 177 Lutetium (177Lu) DOTATOC or 177Lu-DOTATATE received (at least 500 mCi (equivalent to 18.5 GBq), for the entire therapy)
- •PRRT prior to the first combination cycle of PRRT/LAN ATG
结局指标
主要结局
Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)
时间窗: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
次要结局
- PFS rate as per RECIST (Version 1.1)(Up to 12 months post-treatment)
- Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders)(Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment)
- Best Overall Response as per RECIST (Version 1.1)(Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier)
- Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight(Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment)
- Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the presence and in the severity of diarrhoea and flushing, if any(Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment)
- Incidence of vomiting (during infusion only)(Approximately 3 to 6 months after the last PRRT/LAN ATG cycle)
- Objective Response Rate as per RECIST (Version 1.1)(Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment)
- Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the tumour biomarker CgA(Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle)
研究者
研究点 (12)
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