Spots Global Cancer Trial Database for Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
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Trial Identification
Brief Title: Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
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
Study ID: NCT00891800
Conditions
Study Description
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 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
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 harmful.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital, Department of Radiation Therapy, Tampa, Florida, United States
Contact Details
Name: ALison R Calkins, MD
Affiliation: St. Joseph's Hospital, Department of Radiation Therapy
Role: PRINCIPAL_INVESTIGATOR
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