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

Primary Purpose

Breast Cancer Metastatic to the Liver

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brachytherapy
SIR-Sphere
Sponsored by
St. Joseph's Hospital, Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic to the Liver focused on measuring Cancer, Breast, Liver

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital, Department of Radiation Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

All patients will be treated with SIR-Sphere therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2009
Last Updated
June 6, 2011
Sponsor
St. Joseph's Hospital, Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00891800
Brief Title
Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
Acronym
SIRT
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
Lack of study patients
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Joseph's Hospital, Florida

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic to the Liver
Keywords
Cancer, Breast, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All patients will be treated with SIR-Sphere therapy.
Intervention Type
Device
Intervention Name(s)
Brachytherapy
Other Intervention Name(s)
Radiation seeds
Intervention Description
SIR-Sphere contains radiation of Y-90.
Intervention Type
Device
Intervention Name(s)
SIR-Sphere
Intervention Description
Brachytherapy Radiation seeds
Primary Outcome Measure Information:
Title
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALison R Calkins, MD
Organizational Affiliation
St. Joseph's Hospital, Department of Radiation Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital, Department of Radiation Therapy
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.tampabaycancer.com
Description
Website for Dr. Alison Calkins, PI

Learn more about this trial

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

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