NCT00132041已完成不适用
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 18
- 主要终点
- Proportion of Participants With Successful Control of Disease at 18 Months
研究概览
简要总结
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis.
PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.
详细描述
OBJECTIVES:
Primary
- Determine the 18-month successful disease control rate, defined as no identifiable liver tumor by CT scan, in patients with hepatocellular carcinoma and cirrhosis treated with solitary or repetitive percutaneous radiofrequency ablation (RFA).
Secondary
- Correlate tumor size, MELD score, and the number of RFA treatments (solitary or repetitive) with the 18-month successful disease control rate in patients treated with this procedure.
- Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in patients treated with this procedure.
- Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the 18-month successful disease control rate in patients treated with this procedure.
- Correlate tumor size with the local disease control rate in patients treated with this procedure.
- Correlate solitary or repetitive RFA with or without local/regional tumor control with the development of extrahepatic tumor in these patients.
- Determine the local tumor eradication rate, as determined by examination of whole liver specimens or CT scan, in patients treated with this procedure.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatocellular carcinoma (HCC), meeting 1 of the following criteria:
- •Histologically confirmed HCC
- •Discrete non-biopsied hepatic tumors, meeting 1 of the following criteria:
- •Hypervascular tumor > 2 cm by 2 imaging studies
- •Hypervascular tumor > 2 cm by a single imaging study AND alpha-fetoprotein ≥ 400 ng/mL
- •Discrete non-biopsied hypervascular hepatic tumors by 2 consecutive imaging studies (e.g., CT scan or MRI) with documented tumor growth > 1 cm in diameter
- •Histologically confirmed cirrhosis OR typical findings of cirrhosis (i.e., nodular liver, splenomegaly, varices, or ascites) by CT scan and/or MRI scan
- •Single hepatic tumor > 3.0 cm but ≤ 5.0 cm in diameter OR 3 or fewer hepatic tumors ≤ 3.0 cm in diameter
- •No excessive intrahepatic tumor burden (i.e., > 3 hepatic tumors OR a single hepatic tumor > 5 cm OR more than 3 vague hypervascular nodules > 1 cm)
- •Tumor(s) ≥ 1 cm from the main, right, and left portal veins and hollow viscera
- •No hepatic or portal vein tumor invasion
- •Tumor(s) > 1 cm treatable by percutaneous radiofrequency ablation
- •No extrahepatic tumor
- •Not a surgical candidate due to any of the following reasons:
- •Tumor in an unresectable location
- •Comorbid disease
- •Insufficient hepatic reserve
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No uncorrectable coagulopathy
- •Not specified
- •Creatinine ≤ 2.0 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active symptomatic bacterial or fungal infection that is newly diagnosed and/or requires treatment
- •No absolute contraindication to IV iodinated contrast (i.e., history of significant contrast reaction not mitigated by appropriate premedication)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior or concurrent chemotherapy for HCC
- •No prior or concurrent chemoembolization for HCC
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior or concurrent radiotherapy for HCC
- •No prior choledochoenteric anastomosis
- •No prior sphincterotomy of duodenal papilla
- •No prior or concurrent cryoablation for HCC
- •No other prior or concurrent therapy for HCC
- •At least 7 days since prior aspirin
- •At least 24 hours since prior ibuprofen
- •At least 12 hours since prior low molecular weight heparin preparations
排除标准
- 未提供
研究组 & 干预措施
All Patients
Other
patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.
干预措施: radiofrequency ablation (Device)
结局指标
主要结局
Proportion of Participants With Successful Control of Disease at 18 Months
时间窗: 18 months after start of therapy
Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.
次要结局
- Local Tumor Recurrence (Control) Rates(18 months after start of therapy)
- Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation(18 months after start of therapy)
- Effect of Tumor Size on Successful Control of Disease at 18 Months(18 months after start of therapy)
- Impact of Tumor Size on Local Control Rates(18 months after start of therapy)
- Development of Extra-hepatic Tumor(18 months after start of therapy)
- Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan(18 months after start of therapy)
- Remote Tumor Occurrence Rates(18 months after start of therapy)
研究者
研究点 (18)
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