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

Phase 2

Terminated

• Conditions: Breast Cancer Metastatic to the Liver

• Registration Number: NCT00891800
• Lead Sponsor: St. Joseph's Hospital, Florida

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

St. Joseph's Hospital, Department of Radiation Therapy; 🇺🇸 Tampa, Florida, United States