MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
DCIS
MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
1 other identifier
interventional
133
1 country
12
Brief Summary
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2003
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
October 22, 2012
CompletedNovember 6, 2012
November 1, 2012
2.4 years
December 21, 2007
September 20, 2012
November 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Control Rate for Follow-up Period of 5 Years.
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
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.
Secondary Outcomes (4)
Overall Survival
At 5 Years
Cause Specific Survival
At 5 Years
Disease Free Survival
At 5 Years
Cosmetic Evaluations Over Time
At 5 Years
Study Arms (1)
Women with DCIS
EXPERIMENTALWomen with DCIS
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
- University of Southern Californiacollaborator
Study Sites (12)
Arizona Oncology Services
Phoenix, Arizona, 85032, United States
Daniel Freeman Hospital
Inglewood, California, 90301, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars Medical Center
Miami Beach, Florida, 33136, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
NY Presbyterian
New York, New York, 10065, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MD Anderson Cancer Clinic
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy Chenette, Director, Clinical Affairs
- Organization
- Hologic, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Oscar Streeter, MD
University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 4, 2008
Study Start
August 1, 2003
Primary Completion
January 1, 2006
Study Completion
April 1, 2011
Last Updated
November 6, 2012
Results First Posted
October 22, 2012
Record last verified: 2012-11