NCT01643824已完成不适用
A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
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
- 112
- 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 HCC 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 for each arms 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
- •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 were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
- •without evidence of extrahepatic metastasis
- •All target tumors must be encompassable within single irradiation field (15x15 cm maximum)
- •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 ≥ 25,000/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)
- •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
- •multicentric HCCs, except for those with the following two conditions: *multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) *lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
研究组 & 干预措施
Proton Beam Therapy
Experimental
- Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 6GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume), TLV30 <40%, and/or RLV30 <30%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30<50% and RLV30<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30<60%, and/or RLV30<50%
- Dose prescription : 95% isodose volume of prescribed dose encompassed PTV
干预措施: Proton Beam Therapy (Radiation)
结局指标
主要结局
local progression-free survival
时间窗: Up to 1 year
To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
次要结局
- overall survival(Up to 2years until study closed)
研究者
Tae Hyun Kim
Principal investigator
National Cancer Center, Korea
研究点 (2)
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