Trans-Arterial Chemo-Embolization (TACE) vs TACE Plus Stereotactic Body Radio Therapy (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage change in gross tumor volume (GTV)
研究概览
简要总结
This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months.
SECONDARY OBJECTIVES:
I. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of >= 30% at 3 and 6 months.
II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC is staged as Barcelona A to C
- •Treatment with SBRT can occur within 6 weeks of registration
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Patient has
- •Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or
- •Histological confirmation of HCC as determined by the Liver Tumor Board
- •Hemoglobin greater than 10.0 g/dL
- •Total bilirubin less than 3.0 mg/dL
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 X institutional upper limit of normal
- •Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal
- •Total aggregate of maximal dimension of liver tumors is =< 8 cm
- •Cirrhotic patients Child Pugh class A or B (score =< 7)
- •Patient must be determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (magnetic resonance imaging [MRI]/computed tomography [CT] scan) three months post final treatment
- •Absolute neutrophil count >= 1,500/μl
- •Platelet count >= 50,000 μl (after transfusion if required)
- •Life expectancy > 12 weeks
- •Subjects must have the ability to understand and be willing to provide written informed consent
- •Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
- •Women must not be pregnant or nursing
- •Sexually active women must agree to use accepted forms of birth control; acceptable options for birth control will be documented in the consent and discussed with the subject prior to enrollment
排除标准
- •Patient with previous history of abdominal radiation
- •Cirrhotic patients Child Pugh class B with score >= 8
- •Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Evidence of metastatic disease prior to registration
- •Evidence of main portal vein thrombosis
- •History of known cardiac ischemia or stroke within last 6 months
- •Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation
结局指标
主要结局
Percentage change in gross tumor volume (GTV)
时间窗: Baseline to 3 months
Percentage of tumor response as defined as change in longest diameter of tumor compared to original tumor length
Difference in tumor grade
时间窗: Baseline to 3 months
Difference in the grade of tumor (as defined by the RECIST criteria) at T0 and T3 calculated using Chi-square tests.
Difference in mean gross tumor volume (GTV), assessed using the RECIST method
时间窗: Baseline to 3 months
Difference in mean GTV from T0M and T3M calculated by a student t-test
次要结局
- Rate of local progression, based on RECIST criteria(Up to 6 months)
- Rate of downstaging(Up to 6 months)
- Liver transplant achievement(Up to 6 months)
- Grade 3 or 4 adverse events associated with liver tumors(Up to 1 year)
- Survival rate(1 year)