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

NCT ID: NCT00891800

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Breast Cancer Metastatic to the Liver

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

All patients will be treated with SIR-Sphere therapy.

Group Type: EXPERIMENTAL

Brachytherapy

Intervention Type: DEVICE

SIR-Sphere contains radiation of Y-90.

SIR-Sphere

Intervention Type: DEVICE

Brachytherapy Radiation seeds

Interventions

Brachytherapy

SIR-Sphere contains radiation of Y-90.

Intervention Type: DEVICE

SIR-Sphere

Brachytherapy Radiation seeds

Intervention Type: DEVICE

Other Intervention Names

Radiation seeds

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Hospital, Florida

OTHER

Sponsor Role: lead

Responsible Party

St. Joseph's Hospital Tampa FL

Principal Investigators

ALison R Calkins, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital, Department of Radiation Therapy

Locations

St. Joseph's Hospital, Department of Radiation Therapy

Tampa, Florida, United States

Countries

United States

Other Identifiers

IDE # G050256

Identifier Type: -

Identifier Source: secondary_id

SJCI023

Identifier Type: -

Identifier Source: org_study_id