Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma: Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment efficacy (Disease free survival)
研究概览
简要总结
Oligometastasis is a definition that has been described in the past in the 1990s, and in some patients, metastases are not extensive and are limited to a small number of metastases. The local ablative treatment for oligometastasis is not a new concept. In case of liver metastasis from colorectal cancer, long-term survival can be expected if the liver resection is performed. Effectiveness has been demonstrated in studies of adrenal and brain metastasis from lung cancer as well as lung metastasis from sarcoma. A recent non-randomized study reported that patients with oligometastasis improved treatment outcomes with aggressive treatment. This study demonstrated that local ablative treatment for oligometastasis showed better treatment outcomes than expected. Also, the long-term outcomes in SABR-COMET trial showed that the overall survival were increased by 22 months. So far, the standard treatment for metastatic disease is systemic chemotherapy. However, based on these results from studies, active local treatment for patients with oligometastasis is currently being performed in the clinic. In this study, we aimed to apply this concept to patients with hepatocellular carcinoma. To confirm the efficacy and safety of stereotactic radiotherapy in patients with oligometastasis hepatocellular carcinoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. 19 years or older
- •ii. Patients who signed the informed consent form
- •iii. The clinical trial protocol can be complied with at the discretion of the investigator
- •iv. Performance status (based on ECOG) less than 2 (0, 1)
- •v. Patients with life expectancy greater than 3 months
- •vi. Condition in which primary cancer is controlled
- •Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago
- •vii. Number of metastatic lesions up to 5
- •viii. 3 or less metastatic lesions in one metastatic organ
- •ix. Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped)
排除标准
- •i. Serious medical complications that cannot proceed with radiation therapy
- •ii. Previous radiation therapy history at the location where radiation therapy is to be performed
- •iii. malignant pleural effusion
- •iv. When the spinal cord and the tumor are close (the tumor is located within 3 mm)
- •v. In case of brain metastasis requiring surgical intervention
结局指标
主要结局
Treatment efficacy (Disease free survival)
时间窗: 2 year
The disease free survival from the start date of SBRT to date of disease progression or date of death or date of last follow up is evaluated
Treatment efficacy (Overall survival)
时间窗: 2 year
The overall survival of patients from the start date of SBRT to either date of death or date of last follow up is evaluated
次要结局
- Number of participants with treatment-related adverse events (acute and late toxicity) as assessed by CTCAE v4.0(2 year)