Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Tumor Response Rate (Complete Response + Partial Response).
研究概览
简要总结
The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
详细描述
The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic confirmation of solid primary tumor metastatic to liver
- •Age greater than or equal to 18 years old
- •Zubrod performance status less than or equal to 1
- •Negative pregnancy test for women of child bearing potential
- •Informed consent
- •Less than or equal to 3 liver metastases
- •Each lesion must be less than or equal to 6 cm in maximal diameter
- •No prior radiation to lesions being treated
- •Patient is not a surgical candidate or refuses surgery
- •Absolute neutrophil count ≥ 1800
- •Platelets ≥ 100000
- •Hemoglobin ≥8.0
- •Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT
- •At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy
排除标准
- •Contraindications to radiation
- •Pregnant or lactating females who chose to breast feed
- •Patients must have recovered from toxicity of prior therapy
- •Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
- •Patients currently receiving anticoagulation with coumadin or IV heparin
- •Liver cirrhosis
- •Clinical ascites
- •Bilirubin > 3, Albumin < 2.5, liver enzymes 3 times above normal, Creatinine > 1.8
结局指标
主要结局
Tumor Response Rate (Complete Response + Partial Response).
时间窗: 1 year
次要结局
- Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.(1 year)