Evaluation of Accelerated Partial Breast Brachytherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593346
First received: January 2, 2008
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Radiation: brachytherapy

  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
The study opened to participant enrollment on March 12, 2004 and closed to participant enrollment on 12/22/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Accelerated Partial Breast Bracytherapy

Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.

Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.


Participant Flow:   Overall Study
    Accelerated Partial Breast Bracytherapy  
STARTED     151  
COMPLETED     151  
NOT COMPLETED     0  



  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
Accelerated Partial Breast Brachytherapy

Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.

Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.


Baseline Measures
    Accelerated Partial Breast Brachytherapy  
Number of Participants  
[units: participants]
  151  
Age  
[units: years]
Mean (Full Range)
  60   (40 to 85)  
Gender  
[units: participants]
 
Female     151  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     151  
Race  
[units: participants]
 
Caucasian     128  
African-American     23  
Residence at diagnosis  
[units: participants]
 
Urban area     111  
Urban cluster     25  
Rural     15  
Tumor location  
[units: participants]
 
Upper outer quadrant     54  
Upper inner quadrant     46  
Lower outer quadrant     30  
Lower inner quadrant     21  
Pathologic tumor stage [1]
[units: participants]
 
Tis     28  
T1mic     1  
T1a     19  
T1b     52  
T1c     38  
T2     13  
Sentinel lymph node biopsy [2]
[units: participants]
 
Yes     122  
No     1  
[1] Tis: Carcinoma in situ. T1mic: Microinvasive ductal carcinoma T1a: Tumor >1 mm but ≤5 mm in greatest dimension. T1b: Tumor >5 mm but ≤10 mm in greatest dimension. T1c: Tumor >10 mm but ≤20 mm in greatest dimension. T2: Tumor >20 mm but ≤50 mm in greatest dimension.
[2] Only for patients with invasive cancer



  Outcome Measures
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1.  Primary:   Local Control Using Ipsilateral Breast Tumor Recurrence Rates   [ Time Frame: 2 years after treatment completion ]

2.  Primary:   Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates   [ Time Frame: 5 years after treatment completion ]

3.  Primary:   Local Control Using Disease-free Survival Rates   [ Time Frame: 2 years after treatment completion ]

4.  Primary:   Local Control Using Disease-free Survival Rates   [ Time Frame: 5 years after treatment completion ]

5.  Secondary:   Quality of Life Completion   [ Time Frame: 2 years ]

6.  Secondary:   Excellent-good Cosmetic Outcomes - Patient Reported   [ Time Frame: 3 years after completion of therapy ]

7.  Secondary:   Excellent-good Cosmetic Outcomes - Physician Reported   [ Time Frame: 3 years after completion of therapy ]

8.  Secondary:   Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported   [ Time Frame: 3 years ]

9.  Secondary:   Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)   [ Time Frame: Pre-treatment and 3 years ]

10.  Secondary:   Presence or Absence of Complications   [ Time Frame: 5 years after treatment completion ]

11.  Secondary:   Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment   [ Time Frame: 5 years after treatment completion ]

12.  Secondary:   Frequency of Grade 3-4 Toxicities   [ Time Frame: Up to 1 year from completion of therapy ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Imran Zoberi, M.D.
Organization: Washington University School of Medicine
phone: 314-362-8525
e-mail: izoberi@radonc.wustl.edu


No publications provided


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593346     History of Changes
Other Study ID Numbers: 03-1205 / 201011816
Study First Received: January 2, 2008
Results First Received: April 13, 2015
Last Updated: June 1, 2015
Health Authority: United States: Institutional Review Board