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

NCT00891800 | Terminated Phase 2

• 2 other identifiers: SJCI023IDE # G050256
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Metastatic to the Liver

Keywords

Cancer; Breast; Liver

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

All patients will be treated with SIR-Sphere therapy.

Device: Brachytherapy; Device: SIR-Sphere

Interventions

Brachytherapy DEVICE

SIR-Sphere contains radiation of Y-90.

Also known as: Radiation seeds

1

SIR-Sphere DEVICE

Brachytherapy Radiation seeds

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital, Florida: lead

Study Sites (1)

St. Joseph's Hospital, Department of Radiation Therapy

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• ALison R Calkins, MD

  St. Joseph's Hospital, Department of Radiation Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 1, 2009
• Study Start: July 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 7, 2011

Record last verified: 2010-07

Locations

US (1)