Proton Therapy for Lymph Nodes in Breast Cancer (BR01)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01365845
First received: May 19, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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 Phase
Breast Cancer
Radiation: Photon
Radiation: 3D-Proton/Conventional plan or 3D-proton only
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Reduction in volume of heart receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) [ Time Frame: 2 weeks prior to starting radiation therapy. ] [ Designated as safety issue: Yes ]
    Reduction of heart volume exposed to radiation doses ≥ 5 Gy/CGE by at least 50% compared with conventional planning.


Secondary Outcome Measures:
  • Secondary Dosimetric Endpoint [ Time Frame: 2 weeks prior to starting radiation therapy. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008;58:71-96.
Turner-Warwick RT. The lymphatics of the breast. Br J Surg 1959;46:574-82.
Freedman GM, Fowble BL, Nicolaou N, et al. Should internal mammary lymph nodes in breast cancer be a target for the radiation oncologist? Int J Radiat Oncol Biol Phys 2000;46: 805-14.
Marks LB, Munley MT, Bentel GC, et al. Physical and biological predictors of changes in whole-lung function following thoracic irradiation. Int J Radiat Oncol Biol Phys 1997;39:563-570.
Kahan Z, Csenki M, Varga Z, et al. The risk of early and late lung sequelae after conformal radiotherapy in breast cancer patients. Int J Radiat Oncol Biol Phys 2007;68:673-681.
Kwa SL, Lebesque JV, Theuws JC, et al. Radiation pneumonitis as a function of mean lung dose: an analysis of pooled data of 540 patients. Int J Radiat Oncol Biol Phys 1998;42:1-9.
Lind PA, Marks LB, Hardenbergh PH, et al. Technical factors associated with radiation pneumonitis after local +/- regional radiation therapy for breast cancer. Int J Radiat Oncol Biol Phys 2002;52:137-143.
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: UFPTI 1016-BR01
Study First Received: May 19, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Proton Radiation
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014