Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Time to disease progression
研究概览
简要总结
The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (NET) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. G1 or G2)
- •Treatment with lanreotide depot (Somatostatin Analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (LAR) are permitted)
- •Radiographically measurable disease
- •Has signed the most recent written Patient Informed Consent Form
排除标准
- •Known hypersensitivity to lanreotide
- •Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin
- •Patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry
- •Significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)
结局指标
主要结局
Time to disease progression
时间窗: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Time to disease progression will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of first documented disease progression or the date of tumor-related death. In a living patient with no documented disease progression, or if the patient is lost to follow-up, disease progression will be censored at the date of the last evaluable scan. Patients who start a new treatment before they progress will be censored as of the date of last scan. Disease progression is defined for this study as both clinical dimensions of progression in conjunction with a treatment change.
次要结局
- Overall survival(From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised)
- Adverse events(Duration of the study, up to 24 months)
- Change in flushing and diarrhea(Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment))
- Patient satisfaction with treatment(Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment))