Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver (SIRT)
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.
- 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
Breast Cancer Metastatic to the Liver
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
All patients will be treated with SIR-Sphere therapy.
SIR-Sphere contains radiation of Y-90.
Other Names:Device: SIR-Sphere
Brachytherapy Radiation seeds
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.
|United States, Florida|
|St. Joseph's Hospital, Department of Radiation Therapy|
|Tampa, Florida, United States, 33607|
|Principal Investigator:||ALison R Calkins, MD||St. Joseph's Hospital, Department of Radiation Therapy|