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Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082211
First Posted: March 8, 2010
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
Results First Submitted: May 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Radiation: 3D-Conformal External Beam

  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
Partial Breast Re-Irradiation Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total

Participant Flow:   Overall Study
    Partial Breast Re-Irradiation
STARTED   65 
COMPLETED   58 [1] 
NOT COMPLETED   7 
Protocol Violation                4 
No protocol treatment received                3 
[1] Subjects with data available for analysis are considered to have completed the study.



  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.
All eligible patients

Reporting Groups
  Description
Partial Breast Re-Irradiation Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total

Baseline Measures
   Partial Breast Re-Irradiation 
Overall Participants Analyzed 
[Units: Participants]
 58 
Age 
[Units: Years]
Median (Full Range)
 67 
 (44 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      58 100.0% 
Male      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events   [ Time Frame: From the end of radiation to 1 year. ]

2.  Secondary:   In-breast Recurrence   [ Time Frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]

3.  Secondary:   Freedom From Mastectomy   [ Time Frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]

4.  Secondary:   Treatment-related Adverse Events Any Time   [ Time Frame: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis. ]

5.  Secondary:   Distant Metastasis-free Survival   [ Time Frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years. ]

6.  Secondary:   Mastectomy-free Survival   [ Time Frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]

7.  Secondary:   Overall Survival   [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]

8.  Secondary:   Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation   [ Time Frame: After 1 year from the end of radiation. ]

9.  Secondary:   Rate of Circulating Tumor Cells   [ Time Frame: Prior to the start of radiation and 3 weeks after last radiation treatment. ]
Results not yet reported.   Anticipated Reporting Date:   04/2017  

10.  Secondary:   Cosmesis   [ Time Frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years. ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01082211     History of Changes
Other Study ID Numbers: RTOG 1014
CDR0000666991
First Submitted: March 5, 2010
First Posted: March 8, 2010
Results First Submitted: May 3, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017