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Completed

NCT Number: NCT01365845

Proton Therapy for Lymph Nodes in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photon

Radiation

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

3D-Proton/Conventional plan or 3D-proton only

Radiation

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Proton Therapy for Peripheral Lymph Nodes in Breast Cancer

Acronym: BR01

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Jun 3, 2011
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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