A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- local progression - free survival
研究概览
简要总结
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.
详细描述
The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled.
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
- •Hepatocellular Carcinoma 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
- •Inoperable HCC or refusal to surgery
- •Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
- •Patients without evidence of extrahepatic metastasis
- •The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
- •The targeted tumors is more than 2cm away from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel)
- •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 1 on the Eastern Cooperative Oncology Group (ECOG) score
- •Required Entry Laboratory Parameters WBC count ≥ 1,500/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 30,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no uncontrolled ascites
- •No serious comorbidities other than liver cirrhosis
- •Signed informed consent form prior to study entry
排除标准
- •There is evidence of extrahepatic metastasis.
- •Age of <18 years
- •Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7)
- •Previous history of other forms of RT adjacent to target tumors
- •Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- •Multicentric HCCs, except for those with the following two conditions: (i) multinodular aggregating HCC that could be encompassed by single clinical target volume and within single clinical target volume; (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
- •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
时间窗: Up to 5 year
During PBT, patients were assessed weekly and after comletion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0)
次要结局
- overall survival(Up to5 years until study closed)
研究者
Tae Hyun Kim
Principal investigator
National Cancer Center, Korea