NCT01755182终止3 期
Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Pharmacotherapy, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.
National Cancer Institute, Naples12 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 12
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NET of gastroenteropancreatic (GEP), pulmonary or unknown primary site origin
- •Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit)
- •Hepatic involvement ≤50% volume of the organ
- •Radiological evidence of hepatic lesions (contemporaneous progression or appearance of extrahepatic lesions are allowed if not critical sites) that require change or initiation of systemic pharmacotherapy
- •Patients undergoing , previously treated , or never treated with systemic medical therapy are eligible
- •Patients with or without carcinoid syndrome are eligible
- •Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification)
- •Ki67 ≤ 20% (G1-G2)
- •Life expectancy > 6 months
- •Age ≥ 18 and < 80 years
排除标准
- •Previous loco-regional post-surgical treatment
- •Poorly differentiated histology
- •Severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to be detailed), renal failure (creatinine > 2.0 mg/dl) and heart failure (NYHA 3-4 or unstable ischemic heart disease), contraindicating the interventional procedure or influencing the general prognosis (Investigator to provide details of exclusion)
- •Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
- •Patients with only extra-hepatic lesions
研究组 & 干预措施
Pharmacologic therapy
Active Comparator
Patients in this arm receive systemic pharmacologic therapy alone
干预措施: approved pharmacologic therapy (Drug)
TAE and pharmacologic therapy
Experimental
Patients in this arm receive systemic pharmacologic therapy and TAE
干预措施: approved pharmacologic therapy (Drug)
TAE and pharmacologic therapy
Experimental
Patients in this arm receive systemic pharmacologic therapy and TAE
干预措施: TAE (Procedure)
结局指标
主要结局
progression free survival
时间窗: two years
次要结局
- overall survival(3 years)
- number of objective responses(measured at 3 months and 6 months)
- changes in quality of life(up to 6 months)
- worst grade adverse event per patient(6 months)
研究者
研究点 (12)
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