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

This study has been terminated.

(Lack of study patients)

Sponsor:

Information provided by:

St. Joseph's Hospital, Florida

ClinicalTrials.gov Identifier:

NCT00891800

First received: April 29, 2009

Last updated: June 6, 2011

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 29, 2009

Last Updated Date

June 6, 2011

Start Date ^ICMJE

July 2007

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00891800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer Metastatic to the Liver

Intervention ^ICMJE

Device: Brachytherapy
SIR-Sphere contains radiation of Y-90.
Other Names:
- Brachytherapy
- Radiation seeds
Device: SIR-Sphere
Brachytherapy Radiation seeds

Study Arm (s)

Experimental: 1

All patients will be treated with SIR-Sphere therapy.

Interventions:

Device: Brachytherapy
Device: SIR-Sphere

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00891800

Other Study ID Numbers ^ICMJE

SJCI023, IDE # G050256

Has Data Monitoring Committee

Responsible Party

Alison Calkins, MD, St. Joseph's Hospital Tampa FL

Study Sponsor ^ICMJE

St. Joseph's Hospital, Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

ALison R Calkins, MD

St. Joseph's Hospital, Department of Radiation Therapy

Information Provided By

St. Joseph's Hospital, Florida

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top