Proton Therapy for Lymph Nodes in Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01365845

Run by

University of Florida

People needed

18

Starts

2012-04-01

Expected to finish

2018-05-23

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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