Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Overall survival time
研究概览
简要总结
A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.
详细描述
A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma.
An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.
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
- Double
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
- •Inoperable patients
- •histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
- •Age: 18 years or older
排除标准
- •Patient with symptomatic Cholecyst-/Choledocholithiasis
- •Patient with severe psychiatric disease.
- •Participation in another clinical trial within the last 4 weeks.
- •Simultaneous participation in another clinical examination.
- •Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
- •Continuous drug or alcohol abuse.
- •Patient with known HIV infection and antiretroviral therapy.
- •Patient with not controllable infection disease.
- •Pregnancy.
- •Study- and indication-specific exclusion criteria:
- •Secondary malignant tumor without complete remission.
- •Secondary malignant tumor with complete remission but current adjuvant therapy.
- •Preliminary or current therapy with tamoxifen
- •Pretreatment of the HCC.
- •First-time diagnosis > 6 months before inclusion into the study.
- •Severe hepatic encephalopathy, refractory to any treatment.
- •Patients with operable HCC.
- •Contraindication to i.m. injections.
- •Hypersensitivity to octreotide.
结局指标
主要结局
Overall survival time
次要结局
- Costs of the treatment measured by days of in-patient treatment
- Side effects
- Patient compliance
- Quality of life
- Somatostatin receptors in the tumor tissue
- Prognostic relevance of the Somatostatin receptors