Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
NCT ID: NCT01570998
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1259 participants
INTERVENTIONAL
2012-05-18
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (IORT)
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Intraoperative Radiation Therapy
Undergo IORT
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Intraoperative Radiation Therapy
Undergo IORT
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* T1 and T2 (\< 3.5 cm), N0, M0
Exclusion Criteria
* 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
* Patients under the age of 50
* Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
* Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
* Lymphovascular invasion
* High grade
* Tumors \> 3 cm
* Node positive patients
* Prior chemotherapy or hormone therapy
45 Years
FEMALE
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Michael Alvarado, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
University of California, Irvine
Irvine, California, United States
Dignity Health - California Hospital Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Greenwich Hospital
Greenwich, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Cleveland Clinic
Fort Lauderdale, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Community Cancer Center South
Indianapolis, Indiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Marie Yeager Cancer Center, Spectrum Health Lakeland
Saint Joseph, Michigan, United States
Community Hospital at Dobbs Ferry
Dobbs Ferry, New York, United States
Cornell University
Ithaca, New York, United States
Columbia University/Herbert Irving Cancer Center
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, United States
Inova Fairfax Hospital Cancer Center
Fairfax, Virginia, United States
Sentara Port Warwick
Newport News, Virginia, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00461
Identifier Type: REGISTRY
Identifier Source: secondary_id
117515
Identifier Type: -
Identifier Source: org_study_id
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