Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
研究概览
简要总结
This is a phase I trial studying the side effects and best dose of stereotactic radiation therapy (SRT) in treating patients with advanced liver cancer. 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
This is a phase I trial studying the side effects and best dose of stereotactic radiation therapy (SRT) in treating patients with advanced liver cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Participants must have pathologically confirmed hepatocellular carcinoma with at least one tumor with a maximum diameter of ≤ 8 cm and must have Karnofsky performance status ≥ 60% and a life expectancy of at least 12 weeks.
The primary objective is determining the safety of hypofractionated stereotactic radiotherapy in patients with advanced hepatocellular carcinoma by using toxicity profiles described in the Common Terminology Criteria for Adverse Events (CTCAE) V.3.0. Secondary objectives are determining the maximal tolerable SRT dose, objective tumor response rate, the value of 4-Dimensional Computed Tomography (4DCT) in liver cancer planning, and the value of breath gating in liver cancer stereotactic body radiotherapy (SBRT). After completion of study therapy, participants are followed at 1 and 3 months.
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
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)
- •Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm
- •Child-Pugh class A-B cirrhotic status
- •Karnofsky performance status 60-100%
- •Life expectancy ≥ 12 weeks
- •White blood cell count (WBC) ≥ 2,000/μL
- •Platelet count ≥ 60,000/mm³
- •Hemoglobin ≥ 8.5 g/dLINR ≤ 2.3
- •More than 6 months since prior myocardial infarction
- •Prior systemic chemotherapy allowed
- •At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
- •Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in Prothrombin time (PT/INR) and partial thromboplastin time (PTT) exists
排除标准
- •No known central nervous system (CNS) tumors, including metastatic brain disease
- •No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated > 3 years prior to study entry
- •No renal failure requiring hemodialysis or peritoneal dialysis
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection > grade 2
- •New York Heart Association (NYHA) class II-IV congestive heart failure
- •Active coronary artery disease
- •Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- •Uncontrolled hypertension
- •Condition that could jeopardize the safety of the patient or study compliance
- •No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
- •No condition that would prevent the patient from undergoing marker implantation
- •Not pregnant or nursing/negative pregnancy test
- •No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results
- •No prior radiotherapy to the liver
结局指标
主要结局
The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
时间窗: Up to 1 month after Stereotactic Radiation Therapy (SRT) treatment
Toxicity as assessed by NCI CTCAE v3.0 (Adverse Events). Due to delayed toxicities attributable to radiotherapy, all toxicities observed within 1 month after SRT will be scored. Dose limiting toxicity (DLT) is defined as any of following toxicities, that is possibly, probably or definitely related to Stereotactic Radiation Therapy (SRT) occurring within 1 month from the start of treatment: 1. grade 4 or 5 hepatic 2. grade 4 or 5 gastrointestinal 3. grade 4 or 5 thrombocytopenia 4. grade 4 hepatic liver enzyme elevations persisting for ≥ 5 days 5. any adverse event requiring interruption of therapy by ≥ 2 weeks (14 calendar days).
次要结局
- Response at 1-month Post SRT(Measured from first day of SRT to 1-month post SRT.)