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A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00581256
First received: December 20, 2007
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: June 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Radiation: IMRT
Radiation: 3D

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IMRT

Best Delivery-optimized radiotherapy technique (IMRT)

IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.

3DRT

Best 3-dimensional standard PWTF technique

3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease


Participant Flow:   Overall Study
    IMRT   3DRT
STARTED   28   26 
COMPLETED   28   26 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
IMRT

Best Delivery-optimized radiotherapy technique (IMRT)

IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.

3DRT

Best 3-dimensional standard PWTF technique

3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease

Total Total of all reporting groups

Baseline Measures
   IMRT   3DRT   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   26   54 
Age 
[Units: Years]
Mean (Full Range)
 47.8 
 (30 to 69) 
 51.7 
 (25 to 74) 
 50.6 
 (25 to 74) 
Gender 
[Units: Participants]
     
Female   28   25   53 
Male   0   1   1 


  Outcome Measures
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1.  Primary:   The Number of Participants With a Significant Increase in Perfusion Defects (PD)   [ Time Frame: 1 Year ]

2.  Secondary:   Mean Percent Change in Ejection Fraction (LVEF)   [ Time Frame: baseline to approx 1 year ]

3.  Secondary:   Number of Participants With New Lung Perfusion Defects   [ Time Frame: baseline to approx 1 year ]

4.  Secondary:   The Number of Participants That Experience Pericarditis and Pneumonitis   [ Time Frame: approx 1 year ]


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



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00581256     History of Changes
Other Study ID Numbers: UMCC 2004.038
IRB #2002-387 ~ HUM 39607 ( Other Identifier: University of Michigan Medical IRB )
Study First Received: December 20, 2007
Results First Received: June 23, 2016
Last Updated: October 7, 2016
Health Authority: United States: Institutional Review Board