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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
  Purpose

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

Condition Intervention Phase
Breast Cancer Metastatic to the Liver
 Device: Brachytherapy
Device: SIR-Sphere
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital, Florida:

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. [ 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 ]

Estimated Enrollment: 50
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All patients will be treated with SIR-Sphere therapy.
 Device: Brachytherapy
SIR-Sphere contains radiation of Y-90.
Other Names:
  • Brachytherapy
  • Radiation seeds
Device: SIR-Sphere
Brachytherapy Radiation seeds

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891800

Locations
United States, Florida
St. Joseph's Hospital, Department of Radiation Therapy
Tampa, Florida, United States, 33607
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Investigators
Principal Investigator: ALison R Calkins, MD St. Joseph's Hospital, Department of Radiation Therapy
  More Information

No publications provided

Responsible Party: Alison Calkins, MD, St. Joseph's Hospital Tampa FL
ClinicalTrials.gov Identifier: NCT00891800     History of Changes
Other Study ID Numbers: SJCI023, IDE # G050256
Study First Received: April 29, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Joseph's Hospital, Florida:
Cancer
Breast
Liver

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms, Second Primary
 Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013