MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

This study has been completed.
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00586326
First received: December 21, 2007
Last updated: November 2, 2012
Last verified: November 2012
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: DCIS
Intervention: Device: MammoSite Radiation Therapy System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Per the protocol, a total of 125 subjects were to be enrolled at 10-15 nationwide centers. A total of 133 subjects were enrolled at 12 nationwide centers. Patients with DCIS electing to undergo breast conserving therapy with radiation therapy were screened for enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consented patients who were willing to enroll were evaluated prior to surgery. The lumpectomy was performed per the usual standard of care. The MammoSite applicator could be placed at the time of lumpectomy surgery or post-surgery in a separate procedure if adequate evacuated cavity was available as assessed by ultrasound.

Reporting Groups
  Description
Enrolled Women with DCIS who were willing to enroll and consented

Participant Flow for 3 periods

Period 1:   Enrollment to Device Placement-Enrolled
    Enrolled  
STARTED     133  
COMPLETED     118  
NOT COMPLETED     15  
Skin Distance                 6  
Cavity Conformance                 4  
Microinvasion                 2  
Physician Decision                 1  
Withdrawal by Subject                 1  
Unknown                 1  

Period 2:   Device Placed toTreatment-ITT
    Enrolled  
STARTED     118  
COMPLETED     100  
NOT COMPLETED     18  
Skin Distance                 7  
Cavity Conformance                 6  
Microinvasion                 1  
Positive Margins                 3  
Physician Decision                 1  

Period 3:   Treated Through 5-yr Follow Up-Treated
    Enrolled  
STARTED     100  
COMPLETED     74  
NOT COMPLETED     26  
Clinical Reason                 1  
Death                 2  
Medical Reason                 2  
Withdrawal by Subject                 5  
Lost to Follow-up                 14  
Unknown                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treated Subjects enrolled with device placed and treated with partial breast irradiation

Baseline Measures
    Treated  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     69  
>=65 years     31  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 10.5  
Gender  
[units: participants]
 
Female     100  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     100  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Local Control Rate for 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. ]

2.  Secondary:   Overall Survival   [ Time Frame: At 5 Years ]

3.  Secondary:   Cause Specific Survival   [ Time Frame: At 5 Years ]

4.  Secondary:   Disease Free Survival   [ Time Frame: At 5 Years ]

5.  Secondary:   Cosmetic Evaluations Over Time   [ Time Frame: At 5 Years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nancy Chenette, Director, Clinical Affairs
Organization: Hologic, Inc.
phone: 508-263-8770
e-mail: nancy.chenette@hologic.com


No publications provided


Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT00586326     History of Changes
Other Study ID Numbers: MS-700
Study First Received: December 21, 2007
Results First Received: September 20, 2012
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration