Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver

Stopped early · Phase 2

Conditions studied: Breast Cancer Metastatic to the Liver

In brief

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

Key facts

Study ID

NCT00891800

Run by

St. Joseph's Hospital, Florida

People needed

50

Starts

2007-07-01

Expected to finish

2010-12-01

Last updated by the study team

2011-06-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hospital, Department of Radiation Therapy — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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