Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

This study has been terminated.
(The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.)
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00581529
First received: December 20, 2007
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Radiation: IMRT

  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
No text entered.

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
Radiotherapy Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Participant Flow:   Overall Study
    Radiotherapy  
STARTED     34  
COMPLETED     34  
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.
34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underweant mastectomies and were therefore excluded from analysis (comsesis could not be assessed at 5 years). 30 patients were analyzed.

Reporting Groups
  Description
Radiotherapy Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Baseline Measures
    Radiotherapy  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Median (Full Range)
  56    (40 to 80)  
Gender  
[units: participants]
 
Female     30  
Male     0  
Laterality [1]
[units: participants]
 
Left Breast     9  
Right Breast     21  
Histology [2]
[units: participants]
 
DCIS     16  
IDC     14  
Chemotherapy [3]
[units: participants]
 
Yes     5  
No     25  
Endocrine Therapy [4]
[units: participants]
 
Yes     19  
No     11  
Re-excision [5]
[units: participants]
 
Yes     15  
No     15  
[1] Left or right breast
[2] Breast cancer histology: Ductal carcinoma in situ (DCIS) or Invasive ductal carcinoma (IDC).
[3] Did participant receive chemotherapy following APBI (Accelerated partial breast irradiation)?
[4] Did participant receive endocrine therapy following APBI (Accelerated partial breast irradiation)?
[5] Did patients required a second surgical excision to achieve final negative margins?



  Outcome Measures
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1.  Primary:   Rate of Local Control at 5 Years   [ Time Frame: 5 years ]

2.  Primary:   Percentage of Participants That Experience Cosmetic Adverse Events (AEs)   [ Time Frame: 5 years ]

3.  Secondary:   Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods   [ Time Frame: not specific ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Ratio of Percentage of Prescription Dose Received to WBV   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.


  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: Dr. Lori Pierce, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-764-9922
e-mail: ljpierce@umich.edu


No publications provided


Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00581529     History of Changes
Other Study ID Numbers: UMCC 2004.020, IRB #2004-0459 & HUM 44980
Study First Received: December 20, 2007
Results First Received: August 14, 2014
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board