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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:45 - Any
Updated:4/6/2019
Start Date:May 2012
End Date:December 2027

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Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

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.

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.

Inclusion Criteria:

- Suitable for breast conserving surgery

- T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

- Axillary lymph node positive breast cancer

- Invasive lobular cancer

- Tumor size > 3.5 cm

- Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with
ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen

- Multicentric cancer in the same breast as diagnosed by clinical examination,
mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment,
not amenable to excision with negative margins with a single lumpectomy

- Inability to assess pathologic margin status

- Synchronous bilateral breast cancer at the time of diagnosis

- Ipsilateral breast had a previous cancer and/or prior in-field radiation

- Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not
required)

- Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial
treatment with neoadjuvant reducing tumor size

- Previous history of malignant disease does not preclude entry if the expectation of
relapse-free survival at 10 years or greater

- Any factor included as exclusion criteria in the participating center's treatment
policy statement

- Additional exclusion criteria for University of California San Francisco (UCSF) (as
laid out in the Treatment Policy):

- Patients under the age of 50

- Estrogen receptor negative (as defined in Treatment Policy under "Pathology")

- HER2 positive (as defined in Treatment Policy under "HER2")

- Lymphovascular invasion

- High grade

- Tumors > 3 cm

- Node positive patients

- Prior chemotherapy or hormone therapy
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Los Angeles, California 90015
Principal Investigator: Dennis R. Holmes
Phone: 213-742-6400
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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Principal Investigator: Joseph J. Casey
Phone: 954-772-6700
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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345 St Paul Pl
Baltimore, Maryland 21202
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Principal Investigator: Neil B. Friedman
Phone: 410-332-9330
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Berkeley, California 94704
Principal Investigator: Christine S. Chung
Phone: 510-204-5311
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Burlington, Massachusetts 01805
Principal Investigator: Rebecca C. Yang
Phone: 978-538-4039
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Eric D. Donnelly
Phone: 312-926-4247
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128 Ashford Avenue
Dobbs Ferry, New York 10522
Principal Investigator: Pond R. Kelemen
Phone: 914-693-5025
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1872 Saint Luke's Boulevard
Easton, Pennsylvania 18045
Principal Investigator: Lee B. Riley
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Fairfax, Virginia 22031
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Fort Lauderdale, Florida 33308
Principal Investigator: Stephanie Valente
Phone: 216-444-0769
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
(920) 288-8000
Principal Investigator: William L. Owens
Phone: 920-288-8480
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Greenwich, Connecticut 06830
Principal Investigator: Daniela Addeo, MD
Phone: 203-863-3773
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Indianapolis, Indiana 46227
Principal Investigator: Susan C. Lottich
Phone: 317-497-6922
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Irvine, California 92697
949-824-5011
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Ithaca, New York 14853
Principal Investigator: Mary K. Hayes
Phone: 212-746-3610
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: William Small
Phone: 708-216-2559
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New York, New York 10032
Principal Investigator: Eileen P. Connolly
Phone: 212-305-5547
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Newport News, Virginia 23606
Principal Investigator: Richard A. Hoefer
Phone: 757-594-1806
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Poughkeepsie, New York 12601
Principal Investigator: Angela J. Keleher
Phone: 845-483-6500
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San Francisco, California 94115
Principal Investigator: Michael D. Alvarado
Phone: 415-353-7111
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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Walnut Creek, California 94598
Principal Investigator: Marjaneh Moini
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Washington, District of Columbia 20007
Principal Investigator: Shawna C. Willey
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Washington, District of Columbia
Principal Investigator: Marc E. Boisvert
Phone: 202-877-7937
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