NCT00171873已完成3 期
Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Carmen Schade-Brittinger1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2001年9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
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
研究概览
简要总结
Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut
- •curative surgery impossible
- •two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- •Karnofsky-index > 60
- •written informed consent
- •proliferation index for Ki67
排除标准
- •hypersensitivity to octreotide
- •poorly differentiated or small cell neuroendocrine tumors
- •primary tumor outside of the midgut
- •prior treatment with somatostatin-analogue > 4 weeks
- •prior treatment with alpha-interferon, chemotherapy, or chemoembolisation
- •participation in any other clinical trial
- •pregnancy or lactation
- •no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years
- •severe decompensated organ malfunction (heart-, liver- insufficiency)
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo - Sodium chloride intramuscularly every 28 days
干预措施: Placebo (Drug)
Octreotide LAR (Long Acting Release)
Experimental
Octreotide LAR 30 mg intramuscularly every 28 days
干预措施: Octreotide LAR (Long-acting release) (Drug)
结局指标
主要结局
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
时间窗: Up to 7 years
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
次要结局
- Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals(at 3 month intervals)
- Biochemical Response at 3 Month Intervals(at 3 month intervals up to 18 moths)
- Symptom Control at 3 Month Intervals(at 3 month intervals up to 18 moths)
- Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study(at three-month intervals)
- Survival(at least on a monthly basis)
研究者
Carmen Schade-Brittinger
Sponsor-representative
Philipps University Marburg Medical Center
研究点 (1)
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