MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ - Full Text View

Sponsors and Collaborators:	Hologic University of Southern California
Information provided by:	Hologic
ClinicalTrials.gov Identifier:	NCT00586326

Purpose

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Condition	Intervention	Phase
DCIS	Device: MammoSite Radiation Therapy System	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

Further study details as provided by Hologic:

Primary Outcome Measures:

The primary efficacy endpoint of the treatment will be measured by the local control rate for the stated follow-up period of 5 years. [ Time Frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease Free Survival, Cause Specific Survival, Contralateral Breast Failure [ Time Frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits. ] [ Designated as safety issue: Yes ]

Enrollment:	133
Study Start Date:	August 2003
Estimated Study Completion Date:	January 2011
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Women with DCIS	Device: MammoSite Radiation Therapy System The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

Detailed Description:

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pre-Surgery:
- Unicentric pure DCIS
- Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
Post-Surgery:
- Negative histological margins confirmed prior to beginning radiation therapy.
- Margins are positive if there is tumor at the inked margin.
- Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
- Clinically node negative

Exclusion Criteria:

Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
Distant metastases.
Invasive or in-situ lobular carcinoma (post-surgery assessment).
Nonepithelial breast malignancies such as sarcoma or lymphoma.
DCIS that is multicentric in the ipsilateral breast.
Pregnant or lactating.
Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
Collagen vascular diseases
Coexisting medical conditions with life expectancy < 2 years.
Serious psychiatric or addictive disorder
Previously treated contralateral breast carcinoma
Synchronous bilateral breast carcinoma.
Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
Patients with diffuse disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586326

Locations

United States, Arizona
Arizona Oncology Services
Phoenix, Arizona, United States, 85032
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Daniel Freeman Hospital
Inglewood, California, United States, 90301
United States, Florida
Cedars Medical Center
Miami Beach, Florida, United States, 33136
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
NY Presbyterian
New York, New York, United States, 10065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
MD Anderson Cancer Clinic
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Hologic

University of Southern California

Investigators

Principal Investigator:

Oscar Streeter, MD

University of Southern California

More Information

No publications provided

Responsible Party:	Hologic ( Meredith Schiller, Director of Clinical Affairs )
Study ID Numbers:	MS-700
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586326 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hologic:

MammoSite
DCIS

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Site

Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009