Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Local Tumor Recurrence Rate
研究概览
简要总结
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
详细描述
This study is a single site, non-randomized, prospective, phase IV trial.
Composed of 4 patient groups:
- Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- Metastases from neuroendocrine tumors with functional endocrine syndromes
- Unresectable hepatocellular carcinoma (HCC)
- Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient age >= 18 years
- •Zubrod performance status of 0-3
- •Oligometastases (1-3) with aggregate tumor diameter < 6 cm
- •Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
- •Unresectable hepatocellular carcinoma (HCC)
- •Unresectable intrahepatic cholangiocarcinoma (IHCC)
- •Maximum tumor diameter < 6 cm
- •Adequate liver function:
- •Total bilirubin < 3 mg/dL Serum albumin > 2.5 g/dL Serum levels of liver enzymes < 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication
- •Signed study-specific consent form
排除标准
- •Maximum tumor diameter > 6 cm
- •Prior radiotherapy to the liver
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
研究组 & 干预措施
liver metastases
Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
干预措施: Stereotactic body radiosurgery (Radiation)
Primary Liver Tumors
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
干预措施: Stereotactic Body Radiotherapy (Radiation)
结局指标
主要结局
Local Tumor Recurrence Rate
时间窗: 5 years
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
次要结局
- Late Complication Rates(5 years)
研究者
Kathy Baglan, MD
Radiation Oncologist
Mercy Research