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Proton Therapy for Lymph Nodes in Breast Cancer (BR01)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365845
First Posted: June 3, 2011
Last Update Posted: August 23, 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.
Information provided by (Responsible Party):
University of Florida
  Purpose
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 Intervention
Breast Cancer Radiation: Photon Radiation: 3D-Proton/Conventional plan or 3D-proton only

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.


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


Enrollment: 18
Study Start Date: April 2012
Estimated Study Completion Date: January 2019
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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
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
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Julie A Bradley, MD University of Florida Proton Therapy Institute
  More Information

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.

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: August 23, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases