Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT02104895
First received: April 2, 2014
Last updated: May 29, 2016
Last verified: May 2016
Results First Received: November 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Radiation: Accelerated partial breast irradiation (APBI)
Radiation: Whole breast irradiation (WBI)

  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
Whole Breast Irradiation (WBI)

Conventional whole breast irradiation (WBI)

Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)

Partial Breast Irradiation (APBI)

Accelerated partial breast irradiation (APBI)

Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)


Participant Flow:   Overall Study
    Whole Breast Irradiation (WBI)     Partial Breast Irradiation (APBI)  
STARTED     260     260  
COMPLETED     260     246  
NOT COMPLETED     0     14  
Withdrawal by Subject                 0                 14  



  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
Whole Breast Irradiation (WBI)

Conventional whole breast irradiation (WBI)

Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)

Partial Breast Irradiation (APBI)

Accelerated partial breast irradiation (APBI)

Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Total Total of all reporting groups

Baseline Measures
    Whole Breast Irradiation (WBI)     Partial Breast Irradiation (APBI)     Total  
Number of Participants  
[units: participants]
  260     260     520  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     158     142     300  
>=65 years     102     118     220  
Gender  
[units: participants]
     
Female     260     260     520  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Italy     260     260     520  



  Outcome Measures
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1.  Primary:   Ipsilateral Breast Tumor Recurrence   [ Time Frame: 5-year ]

2.  Secondary:   Acute Skin Toxicity   [ Time Frame: 5 years ]

3.  Secondary:   Excellent Cosmesis   [ Time Frame: 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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Icro Meattini
Organization: Radiation-Oncology Unit, AOU Careggi, Florence University, Florence, Italy
phone: +39055794 ext 7719
e-mail: icro.meattini@unifi.it


Publications of Results:


Responsible Party: Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02104895     History of Changes
Other Study ID Numbers: APBI-IMRT-Florence
Study First Received: April 2, 2014
Results First Received: November 25, 2015
Last Updated: May 29, 2016
Health Authority: Italy: The Italian Medicines Agency