A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- local progression-free survival(LPES)
研究概览
简要总结
This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.
详细描述
The sample size for this study was based on a non-inferiority design. Primary objective: estimate local progression-free survival (LPFS) rate in two treatments Primary endpoint: 2-year LPFS rate Expected 2-year LPFS rate in the RFA: 85% Accural time and follow up time: 24 months and 24 months, respectively. Precision for 2-year LPFS rate estimation: Allowing a difference of 15% as the non-inferiority margin, with a power of 80% and a type I error level of 5%, evaluable 68 patients are required.
Considering 5% of follow-up loss, we need 72 patients in each arm, so a total of 144 patients will be enrolled.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
- •HCC patients who had recurrent or residual tumor after other treatments
- •without evidence of extrahepatic metastasis
- •the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2
- •no previous treatment to target tumors by other forms of RT
- •liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
- •Age of ≥18 years
- •performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
- •WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no ascites)
- •no serious comorbidities other than liver cirrhosis
- •written informed consent
排除标准
- •evidence of extrahepatic metastasis
- •age < 18 years
- •liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7) or uncontrolled cases of active chronic hepatitis B
- •previous history of other forms of RT adjacent to target tumors
- •poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- •pregnant or breast feeding status
- •previous history uncontrolled other malignancies within 2 years
结局指标
主要结局
local progression-free survival(LPES)
时间窗: up to 2 year
To evaluate the local progression-free survival for 2 years
次要结局
- disease-free survival (DFS)(up to 2 years until study closed)
研究者
Joong-Won Park
Principal Investigator
National Cancer Center, Korea