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Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

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ClinicalTrials.gov Identifier: NCT00581529
Recruitment Status : Terminated (The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.)
First Posted : December 27, 2007
Results First Posted : August 28, 2014
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Radiation: IMRT

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 56 
 (40 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      30 100.0% 
Male      0   0.0% 
Laterality [1] 
[Units: Participants]
 
Left Breast   9 
Right Breast   21 
[1] Left or right breast
Histology [1] 
[Units: Participants]
 
DCIS   16 
IDC   14 
[1] Breast cancer histology: Ductal carcinoma in situ (DCIS) or Invasive ductal carcinoma (IDC).
Chemotherapy [1] 
[Units: Participants]
 
Yes   5 
No   25 
[1] Did participant receive chemotherapy following APBI (Accelerated partial breast irradiation)?
Endocrine Therapy [1] 
[Units: Participants]
 
Yes   19 
No   11 
[1] Did participant receive endocrine therapy following APBI (Accelerated partial breast irradiation)?
Re-excision [1] 
[Units: Participants]
 
Yes   15 
No   15 
[1] Did patients required a second surgical excision to achieve final negative margins?


  Outcome Measures

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 ]

4.  Secondary:   Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



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 ( Other Identifier: University of Michigan Medical IRB )
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: August 14, 2014
Results First Posted: August 28, 2014
Last Update Posted: October 31, 2017