NCT03112694已完成不适用
A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 93
- 试验地点
- 8
- 主要终点
- Response to treatment
研究概览
简要总结
The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
- •Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
- •Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)
排除标准
- •Patients with other malignant disease
- •Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
- •Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
- •Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
- •Patients with NET familial genetic syndrome (i.e., MEN1)
结局指标
主要结局
Response to treatment
时间窗: 4 months (data collection duration)
Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement)
次要结局
- Progression-free survival, after treatment with octreotide(4 months (data collection duration))
- Severity of Adverse Events(4 months (data collection duration))
- Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available(4 months (data collection duration))
- Duration of response to lanreotide, after treatment with octreotide(4 months (data collection duration))
- Duration of treatment with octreotide and duration of treatment with lanreotide(4 months (data collection duration))
- Reasons for switching from octreotide to lanreotide(4 months (data collection duration))
- Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available(4 months (data collection duration))
- Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available(4 months (data collection duration))
研究者
研究点 (8)
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