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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 Description
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Brief Summary:
The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Photon Radiation: 3D-Proton/Conventional plan or 3D-proton only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
Actual Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Conventional photon plan
 Radiation: Photon
50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
Experimental: 2
3D-Proton/Conventional plan or 3D-proton only
 Radiation: 3D-Proton/Conventional plan or 3D-proton only
50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction


Outcome Measures
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Primary Outcome Measures :
  1. Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) [ Time Frame: 2 weeks prior to starting radiation therapy. ]
    A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.


Secondary Outcome Measures :
  1. Secondary Dosimetric Endpoint [ Time Frame: 2 weeks prior to starting radiation therapy. ]
    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.

  2. Assessment of Acute Side Effects [ Time Frame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks. ]
    Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.

  3. 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. ]

    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.


  4. Assessment of Cardiac Function Markers [ Time Frame: after treatment ]
    Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
  • Patients must have undergone either mastectomy or breast conservation surgery.
  • Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
  • Patient must require peripheral lymph node radiation per physician discretion.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior radiotherapy to the area of interest.
  • Prior history of cardiovascular disease per physician discretion.
  • Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365845


Locations
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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Julie A Bradley, MD University of Florida Proton Therapy Institute
More Information
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Additional Information:

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.

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01365845    
Other Study ID Numbers: IRB201701740
UFPTI 1016-BR01 ( Other Identifier: University of Florida Project # )
First Posted: June 3, 2011    Key Record Dates
Results First Posted: December 5, 2014
Last Update Posted: June 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Proton Radiation
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases