Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00891800
Recruitment Status : Terminated (Lack of study patients)
First Posted : May 1, 2009
Last Update Posted : June 7, 2011
Sponsor:
Information provided by:
St. Joseph's Hospital, Florida

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE May 1, 2009
Last Update Posted Date June 7, 2011
Study Start Date  ICMJE July 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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. ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Name: Radiation seeds
  • Device: SIR-Sphere
    Brachytherapy Radiation seeds
Study Arms  ICMJE 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
 (submitted: April 30, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891800
Other Study ID Numbers  ICMJE SJCI023
IDE # G050256
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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