An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) in Patients Treated With TACE and Y90
研究概览
简要总结
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression.
Secondary
- Characterize the safety and toxicity profile of these regimens.
- Determine the need for subsequent treatment in these patients.
- Determine tumor response in these patients
- Characterize change in quality of life and functional status in these patients.
- Determine time to progression in these patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I (radioembolization)
Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
干预措施: yttrium Y 90 glass microspheres (Radiation)
Arm II (transarterial chemoembolization [TACE])
Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Time to Progression (TTP) in Patients Treated With TACE and Y90
时间窗: Up to 6 yrs
Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. Patients have repeat imaging done (MRI or CT) at 1-month post procedure and then every 3 months after that. TTP and overall survival (OS) analyses were calculated from day of randomization by Kaplan-Meier analysis on intention-to-treat (ITT) basis. Progression (which is detected on follow-up imaging scans) was defined as: 1. Progression by World Health Organization (WHO) response criteria 25% increase in bidimensional cross product. 2. Progression by European Assosciation for the Study of the Liver (EASL): 25% increase in arterial enhancement 3. Malignant portal vein tumor thrombus development 4. Index lesion: lesions requiring re-treatment because of worsening circumferential enhancement 5. Development of new lesions or extra-hepatic metastases.
次要结局
- Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment(up to 6 years)
- Overall Survival(From day of randomization until date of death, or liver transplant or 7/15/2016, whichever came first, assessed up to 6 years)
研究者
Riad Salem
Chief Vascular and Interventional Radiology
Northwestern University