A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Severe Treatment-related Toxicity
研究概览
简要总结
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).
SECONDARY OBJECTIVES:
I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.
II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.
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
- •Life expectancy > 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •HCC diagnosed by either of the following approaches:
- •Histologic confirmation of HCC on biopsy
- •Evidence of vascular enhancement of suspected lesion on at least two imaging techniques
- •Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is > 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C
- •HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon
- •Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)
- •Prior liver resection or ablative therapy is permitted
- •Prior transarterial chemoembolization (TACE) is permitted
- •Patients must have recovered from the effects of previous therapy
- •Maximal tumor size of 15 cm and > 700 cc of uninvolved liver
- •Hemoglobin > 9.0 g/L
- •Absolute neutrophil count >= 1.0 bil/L
- •Platelets >= 70,000 bil/L
- •Total bilirubin < 2 mg/dL
- •International normalized ratio (INR) =< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 6 times upper range of normal
排除标准
- •Active hepatitis or encephalopathy related to liver failure
- •Prior radiation therapy to the upper abdomen or thorax
- •Lesions within 1 cm from the stomach
- •Prior uncontrolled, life threatening malignancy within the previous 6 months
- •Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment
- •Previous gastric, duodenal or variceal bleed within the past 2 months
- •Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months
研究组 & 干预措施
Treatment (SBRT)
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Severe Treatment-related Toxicity
时间窗: Within 3 months of SBRT
The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
次要结局
- Overall Survival (OS)(Time from study entry to death from any cause, assessed up to 2 years)
- Cancer Specific Survival (CSS)(Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years)
- Time to Local Progression (TTLP) of Treated Lesions(From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years)
研究者
Nitin Ohri
Principal Investigator
Albert Einstein College of Medicine