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

NCT00891800 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-07

No results posted yet for this study

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

Conditions

  • Breast Cancer Metastatic to the Liver

Interventions

DEVICE

Brachytherapy

SIR-Sphere contains radiation of Y-90.

DEVICE

SIR-Sphere

Brachytherapy Radiation seeds

Sponsors & Collaborators

  • St. Joseph's Hospital, Florida

    lead OTHER

Principal Investigators

  • ALison R Calkins, MD · St. Joseph's Hospital, Department of Radiation Therapy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00891800 on ClinicalTrials.gov