Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 主要终点
- Treatment succes vs treatment failure
研究概览
简要总结
This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron & Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent GEP NET Ki 67 ≤ 10 %
- •Histologically or cytologically confirmed GEP NET
- •Appearance of carcinoid syndrome maximum 6 months before the inclusion
- •Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2
- •Positive somatostatin receptor scintigraphy
- •>18 years
- •Life expectancy of at least 12 weeks
排除标准
- •Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET.
- •Previous malignancy in the last past 3 years except malignancies estimated as completely cured.
- •Current pregnancy or breast feeding
- •Concomitant anti-tumoral treatment, except external beam radiotherapy
研究组 & 干预措施
Treatment
All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.
干预措施: Sandostatin (Drug)
结局指标
主要结局
Treatment succes vs treatment failure
时间窗: 2 years
The primary endpoint is defined as follows: * Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. * Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR. The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.
次要结局
- Rate of diarrhea and flushes(2 years)
- Impact of increased dose(2 years)
- Toxicities(2 years)
- Symptoms(2 years)
- Changes in Quality of life(2 years)
- Effect on tumor control(2 years)
- Correlation dose/frequency(2 years)