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

St. Joseph's Hospital, Florida

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer Metastatic to the Liver

Treatments: Device: SIR-Sphere; Device: Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00891800

SJCI023

IDE # G050256

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Description:

All patients will be treated with SIR-Sphere therapy.

Treatment:

Device: SIR-Sphere

Device: Brachytherapy