Spots Global Cancer Trial Database for Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
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Trial Identification
Brief Title: Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Official Title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
Study ID: NCT01570998
Study Description
Brief Summary: 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 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.
Keywords
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, District of Columbia, United States
MedStar Washington Hospital Center, Washington, 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
Contact Details
Name: Michael Alvarado, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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