Last updated on November 2019

Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery


Brief description of study

This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Clinical Study Identifier: NCT01570998

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Mercy Medical Center

Baltimore, MD United States
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MedStar Washington Hospital Center

Washington, D.C., United States
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Vassar Brothers Medical Center

Poughkeepsie, NY United States
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Cornell University

Ithaca, NY United States
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Aurora BayCare Medical Center

Green Bay, WI United States
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Northwestern University

Chicago, IL United States
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Holy Cross Hospital

Fort Lauderdale, FL United States
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Sentara Port Warwick

Newport News, VA United States
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Cleveland Clinic

Fort Lauderdale, FL United States
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Community Cancer Center South

Indianapolis, IN United States
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Community Hospital at Dobbs Ferry

Dobbs Ferry, NY United States
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Greenwich Hospital

Greenwich, CT United States
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