Clinical trial NCT00891800: Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer Metastatic to the Liver
Keywords: Cancer
Breast
Liver
Lead sponsor: St. Joseph's Hospital, Florida
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: St. Joseph's Hospital, Department of Radiation Therapy
state: Florida
Study officials:
affiliation: St. Joseph's Hospital, Department of Radiation Therapy
name: ALison R Calkins, MD
role: PRINCIPAL_INVESTIGATOR
References: