ClinicalTrials.gov
ClinicalTrials.gov Menu

Proton Therapy for Lymph Nodes in Breast Cancer (BR01)

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.
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
Enrollment 18

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction Phase Conventional Photon Plan 3D-Proton/Conventional Plan or 3D-proton Only
Hide Arm/Group Description 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): 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: 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.

Period Title: Induction Phase
Started 18 0 0
Completed 18 0 0
Not Completed 0 0 0
Period Title: Treatment Phase
Started 0 0 18
Completed 0 0 18
Not Completed 0 0 0
Arm/Group Title Breast Patients Planned With Both Proton & Conventional Plans
Hide Arm/Group Description

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

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
52
(37 to 73)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  83.3%
>=65 years
3
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
18
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
Hide Description A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.
Time Frame 2 weeks prior to starting radiation therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Photon Plan 3D-Proton/Conventional Plan or 3D-proton Only
Hide Arm/Group Description:
Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
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 per fraction
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: % of heart receiving >= 5 Gray (Gy)
34.7
(6.9 to 60.0)
2.7
(0.1 to 12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Photon Plan, 3D-Proton/Conventional Plan or 3D-proton Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Non-parametric paired t-test (Wilcoxon)
Estimated Value 29.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Secondary Dosimetric Endpoint
Hide Description Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.
Time Frame 2 weeks prior to starting radiation therapy.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Assessment of Acute Side Effects
Hide Description Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.
Time Frame Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Assessment of Longterm Side Effects and Disease Specific End Points.
Hide Description

Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.

Analyze local control, progression-free survival, and overall survival.

Time Frame 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Assessment of Cardiac Function Markers
Hide Description Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.
Time Frame after treatment
Outcome Measure Data Not Reported
Time Frame From start of radiation therapy to date of last follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Breast Patients Planned With Both Proton & Conventional Plans
Hide Arm/Group Description

All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.

Each patient was planned with both proton and conventional plans and the superior plan was 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

All-Cause Mortality
Breast Patients Planned With Both Proton & Conventional Plans
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Breast Patients Planned With Both Proton & Conventional Plans
Affected / at Risk (%) # Events
Total   6/18 (33.33%)    
Infections and infestations   
Skin infection  1 [1]  2/18 (11.11%)  2
Injury, poisoning and procedural complications   
Radiation dermatitis  2 [1]  4/18 (22.22%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (4.0)
[1]
All patients ultimately treated under the proton plan, so the denominator for this event refers exclusively to the proton arm and not conventional.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Breast Patients Planned With Both Proton & Conventional Plans
Affected / at Risk (%) # Events
Total   11/18 (61.11%)    
Gastrointestinal disorders   
Esophagitis  2  5/18 (27.78%)  5
General disorders   
Fatigue  2  7/18 (38.89%)  7
Nausea  2  1/18 (5.56%)  1
Infections and infestations   
Wound infection  2  2/18 (11.11%)  2
Infection  2  1/18 (5.56%)  1
Reproductive system and breast disorders   
Breast atrophy  1  1/18 (5.56%)  1
Breast pain  2  5/18 (27.78%)  5
Lymphedema  2  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2  1/18 (5.56%)  1
Pneumonitis  2  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Hyperpigmentation  2  1/18 (5.56%)  1
Skin ulceration  2  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (4.0)
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
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