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Proton Therapy for Lymph Nodes in Breast Cancer (BR01)

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ClinicalTrials.gov Identifier: NCT01365845
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : December 5, 2014
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Radiation: Photon
Radiation: 3D-Proton/Conventional plan or 3D-proton only

  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
Induction Phase During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
Conventional Photon Plan

Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction

This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment.

3D-Proton/Conventional Plan or 3D-proton Only

3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy

This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment.


Participant Flow for 2 periods

Period 1:   Induction Phase
    Induction Phase   Conventional Photon Plan   3D-Proton/Conventional Plan or 3D-proton Only
STARTED   18   0   0 
COMPLETED   18   0   0 
NOT COMPLETED   0   0   0 

Period 2:   Treatment Phase
    Induction Phase   Conventional Photon Plan   3D-Proton/Conventional Plan or 3D-proton Only
STARTED   0   0   18 
COMPLETED   0   0   18 
NOT COMPLETED   0   0   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.
No text entered.

Reporting Groups
  Description
Breast Patients Planned With Both Proton & Conventional Plans

Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.

Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction

Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction


Baseline Measures
   Breast Patients Planned With Both Proton & Conventional Plans 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Median (Full Range)
 52 
 (37 to 73) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15  83.3% 
>=65 years      3  16.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)   [ Time Frame: 2 weeks prior to starting radiation therapy. ]

2.  Secondary:   Secondary Dosimetric Endpoint   [ Time Frame: 2 weeks prior to starting radiation therapy. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Assessment of Acute Side Effects   [ Time Frame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Assessment of Longterm Side Effects and Disease Specific End Points.   [ Time Frame: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Assessment of Cardiac Function Markers   [ Time Frame: after treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Julie Bradley
Organization: University of Florida Proton Therapy Institute
phone: 904-588-1800
e-mail: jbradley@floridaproton.org


Publications:
N. Xu, M. Ho, C.G. Morris, N.P. Mendenhall. Proton treatment of peripheral lymph nodes in breast cancer. Int J Radiat Oncol Biol Phys 2010; 78: S803.


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01365845     History of Changes
Other Study ID Numbers: IRB201701740
UFPTI 1016-BR01 ( Other Identifier: University of Florida Project # )
First Submitted: May 19, 2011
First Posted: June 3, 2011
Results First Submitted: September 11, 2014
Results First Posted: December 5, 2014
Last Update Posted: June 29, 2018