Status:
TERMINATED
Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
Lead Sponsor:
St. Joseph's Hospital, Florida
Conditions:
Breast Cancer Metastatic to the Liver
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 canc...
Detailed Description
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 harmfu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00891800
Start Date
July 1 2007
End Date
December 1 2010
Last Update
June 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Hospital, Department of Radiation Therapy
Tampa, Florida, United States, 33607