MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
NCT ID: NCT00586326
Last Updated: 2012-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2003-08-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Women with DCIS
Women with DCIS
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
FEMALE
No
Sponsors
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University of Southern California
OTHER
Hologic, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Oscar Streeter, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Arizona Oncology Services
Phoenix, Arizona, United States
Daniel Freeman Hospital
Inglewood, California, United States
University of Southern California
Los Angeles, California, United States
Cedars Medical Center
Miami Beach, Florida, United States
St. Agnes Hospital
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
NY Presbyterian
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
MD Anderson Cancer Clinic
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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MS-700
Identifier Type: -
Identifier Source: org_study_id