Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.
详细描述
Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent provided
- •18~75 years old
- •patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence
- •without any lymph node or distant metastasis (any T N0M0)
- •liver function: Child-Pugh A or B
- •Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1
- •life expectation>6 months
- •no dysfunction of major organs
- •no prior radiotherapy
- •negative for human immunodeficiency virus syndrome (HIV)
- •Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT
排除标准
- •malignant tumors of other sits
- •combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection
- •surgery performed in other hospitals without details
- •pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
结局指标
主要结局
overall survival
时间窗: 3 year
the rate of overall survival for 3 year
次要结局
- Number of Participants with Adverse Events(3 years)
- disease free survival(3 years)
- local recurrence free survival(3 years)
研究者
Tao Zhang
Principal Investigator
Chinese Academy of Medical Sciences