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

Breast Cancer Metastatic to the Liver Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00891800
• Other study ID #: SJCI023
• Secondary ID: IDE # G050256
• Status: Terminated
• Phase: Phase 2
• First received: April 29, 2009
• Last updated: June 6, 2011
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: St. Joseph's Hospital, Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer Metastatic to the Liver
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	St. Joseph's Hospital, Department of Radiation Therapy	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital, Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	No