NCT02221778进行中（未招募）2 期
Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Local Progression Free Survival
研究概览
简要总结
This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
- •Tumor Stage
- •liver only disease
- •tumor thrombus at segment is allowed
- •no extra hepatic metastases
- •tumor encompassing less than 50% of hepatic volume
- •previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
- •presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
- •Maximum lesion size of 10 cm.
- •Liver residual volume equal or more than 700cc or 40% of total liver volume
- •Child-Pugh A or absence of hepatic cirrhosis
- •absence of encephalopathy or ascitis on clinical exam
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Lab exams:
- •hemoglobin > or equal 8 mg/dl
- •neutrophils > or equal 1.200/mm³
- •platelets > or equal 45.000/mm³
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
- •bilirubin equal or < 2 mg/dl
- •international normalized ratio (INR) < 1.7
- •serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance > or equal 60 ml/min
- •Albumin >2.8 mg/dl
- •not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.
排除标准
- •Patients with more than 5 discrete lesions in the liver
- •Main or common biliary duct invasion
- •Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
- •Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
- •Previous radiation to upper abdomen
- •Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
- •Patients with ischemic myocardial infarction within the last 6 months
- •Patients with large esophageal varices with red color sign or bleeding within the last 3 months
- •Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
- •Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
- •Patients unable to understand and sign written informed consent
结局指标
主要结局
Local Progression Free Survival
时间窗: 5 years
Local Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated. The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study. Local Progression Free Survival will be defined as increase of 20% in the sum of all diameters of the treated lesions. Time-to-event will be counted from the initiation of SBRT
次要结局
- Overall Survival(5 years)
- Distant Progression Free Survival(5 years)
- Toxicity(5 years)
研究者
Andre Tsin Chih Chen
MD
University of Sao Paulo
研究点 (2)
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