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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:
ClinicalTrials.gov Identifier:
NCT00891800
First Posted: May 1, 2009
Last Update Posted: June 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Joseph's Hospital, Florida
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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. ]

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 Name: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Submitted: April 29, 2009
First Posted: May 1, 2009
Last Update Posted: June 7, 2011
Last Verified: July 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases