A Phase II Feasibility Study to Assess the Use of SIR-Sphere in Patients With Breast Cancer Who Have Chemotherapy-Resistant Disease in the Liver
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work.
研究概览
简要总结
The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients.
Criteria:
- Breast cancer
- Clinical evidence of metastatic disease in the liver
- Performance status (0-2)
- Not pregnant
- Laboratory values received after any prior chemotherapy
- Normal Pt/PTT
- recovered from any chemotherapy side-effects
- No prior radiation therapy to the liver
- No other MAJOR site of cancer such as lungs or brain
- No uncontrolled infections
- a candidate for surgical resection or ablation therapy
详细描述
Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented breast cancer
- •Clinical evidence of mets to the liver
- •Performance status of 0-2
- •Life expectancy of greater equal to 3 months
- •Not pregnant
- •4 weeks or more since last radiation therapy
- •Recovered from all side effects of prior chemotherapy
- •Not needing concurrent chemotherapy
- •recovered laboratory values
- •Bilirubin < 2.0
排除标准
- •Candidate for surgical resection or ablation of liver lesion/s
- •Prior radiation therapy to the liver
- •Co-Morbid disease
- •pulmonary insufficiency
- •Portal vein thrombosis
- •Contraindications to angiography
- •> 20 % lung shunting on MAA
- •Diffuse extra-hepatic disease
- •Concurrent chemotherapy OR capecitabine with 8 weeks
- •Failed MAA
- •Uncontrolled active infection
- •Severe liver dysfunction
结局指标
主要结局
Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work.
时间窗: Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver.
次要结局
未报告次要终点