Brachytherapy Radiation Directly to the Liver in Breast C... | NCT00891800

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

NCT00891800

Sponsor

St. Joseph's Hospital, Florida

Status

Terminated

Last Update Posted

Jun 7, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Breast Cancer Metastatic to the Liver

Interventions

Brachytherapy
SIR-Sphere

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDE # G050256

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of study patients

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 29, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2011

Last Update Posted Date

Jun 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	All patients will be treated with SIR-Sphere therapy.	Device: Brachytherapy Device: SIR-Sphere

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brachytherapy	Device	SIR-Sphere contains radiation of Y-90.	1	Radiation seeds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ALison R Calkins, MD	St. Joseph's Hospital, Department of Radiation Therapy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital, Department of Radiation Therapy		Tampa	Florida	33607	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001918	Brachytherapy

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided