Proton Beam Radiotherapy Versus Switching Control Radiofrequency Ablation for Patients With Medium (>3, ≦5 cm) or Large (>5, ≦7cm) Treatment-naive Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Local control rate (treatment in-field control rate)
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic viral hepatitis is common. Patients with HCC typically have impaired liver function because of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of them are appropriate candidates for surgery. The 5-year overall survival for patients treated by surgery is approximately 30%-70%. For those not treated with surgery, liver function affected by an underlying liver disease has a strong influence on clinical outcomes, and complicates treatment strategies further than for other tumors. Maximal preservation of normal liver volume and function is an important consideration in the choice of treatment.
Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and nearly no major complications. The investigators also retrospectively reviewed 75 index tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31 December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-, 2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81% and 89%, 83%, 67%, respectively.
Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton therapy was better than radiofrequency ablation, this prospective trial is aimed to compare the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery or refuse surgery. This prospective study has high possibility to confirm the role of proton beam in HCC.
Along with the clinical trial, the investigators will also use next generation sequencing (NGS) to exam gene expression profile of tumor samples and find out candidate genes related to local control, intrahepatic control (treatment out-field control in liver), regional lymph node relapse, distant metastasis, and treatment response in HCC.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed hepatocellular carcinoma or lesion with typical triphasic CT or MRI imaging features for HCC
- •Single tumor and tumor size > 3cm, ≦7cm in diameter
- •Patients are unsuitable for resection or unwilling to accept surgery.
- •Age ≥20 years old
- •Eastern Cooperative Oncology Group performance status score of 0 or 1
- •Child-Pugh score ≦ 8
- •Willing to sign informed consent regarding participation in this study
排除标准
- •Patients have received any treatment for HCC before this study
- •Pregnancy/breast feeding women
- •Tumor adjacent to bowel <1cm
- •Extrahepatic metastasis
- •Extrahepatic invasion
- •Portal or hepatic vein tumor invasion/thrombosis
- •Uncontrolled ascites
- •Glomerular filtration rate (GFR) < 30 ml/min*
- •Platelet count < 50,000/L*
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years
- •Ongoing medically significant active infection.
- •MRI incompatible devices
- •* Baseline laboratories results must be within the protocol range prior to sign informed consent. Repeat lab tests are permitted to evaluate eligibility during the Screening Period.
结局指标
主要结局
Local control rate (treatment in-field control rate)
时间窗: 3-year
次要结局
- Distant metastasis free survival rate(5-year)
- Local control rate (treatment in-field control rate)(5-year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3-year)
- Overall survival rate(5-year)
- Intrahepatic control rate(5-year)
- Patient report outcome - quality of life as assessed by the functional assessment of cancer therapy - hepatobiliary (FACT-Hep)(3-year)
- Patient report outcome - fatigue as assessed by the functional assessment of cancer therapy (FACT-F)(3-year)
- Patient report outcome - pain as assessed by the brief pain inventory-short form (BPI-SF)(3-year)
- Patient report outcome - symptom distress as assessed by the Memorial symptom assessment scale-short form (MSAS-SF)(3-year)
- Patient report outcome - treatment satisfaction as assessed by the functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G)(3-year)
- Patient report outcome - quality of life as assessed by the EQ-5D-3L(3-year)
研究者
Shi-Ming Lin
Director of Liver Research Unit
Chang Gung Memorial Hospital