Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002873
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.
PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer.
- Detailed Description
OBJECTIVES: I. Evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local cancer control rate experience with brachytherapy used as the sole method of radiotherapy in women with stage I/II breast cancer treated with tylectomy who have histologically assessed negative surgical margins, less than 4 positive axillary nodes, and no extracapsular nodal extension or extensive intraductal component. II. Reduce the total treatment time of breast irradiation from 6 weeks to 4-5 days in these patients.
OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery. All patients receive brachytherapy to the target volume (as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for dose distribution to five planes. Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs low-dose rate) over 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (232)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Swedish Hospital Tumor Institute
🇺🇸Seattle, Washington, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Clarion Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Meritcare Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
UNI-MED Medical Center
🇺🇸Minot, North Dakota, United States
Glendale Memorial Hospital and Health Center
🇺🇸Glendale, California, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscallosa, Alabama, United States
Urology Associates - Mobile AL
🇺🇸Mobile, Alabama, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Stanford University
🇺🇸Stanford, California, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Florida Radiation Oncology Group
🇺🇸Orange Park, Florida, United States
Radiation Oncology Affiliates of Maryland, P.A.
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Virginia Baptist Hospital
🇺🇸Lynchburg, Virginia, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Green Mountain Oncology Group
🇺🇸Rutland, Vermont, United States
St. Joseph's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
California Cancer Center
🇺🇸Fresno, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Cancer Care Center
🇺🇸Pomona, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Mercy Medical Center - Redding
🇺🇸Redding, California, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Western Baptist Hospital
🇺🇸Paducah, Kentucky, United States
Allegheny University Hospitals- Hahnemann
🇺🇸Philadelphia, Pennsylvania, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center
🇺🇸Racine, Wisconsin, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Santa Cruz Radiation Oncology Medical Group, Inc.
🇺🇸Santa Cruz, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Radiation Oncology Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Lykes Center for Radiation Therapy
🇺🇸Clearwater, Florida, United States
Radiation Therapy Associates - Fort Myers
🇺🇸Fort Myers, Florida, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
West Florida Cancer Institute - Pensacola
🇺🇸Pensacola, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
InterCommunity Cancer Center at Rome
🇺🇸Rome, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Central Illinois
🇺🇸Springfield, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Medical Center at Bowling Green
🇺🇸Bowling Green, Kentucky, United States
St. Joseph's Radiation Oncology Center
🇺🇸South Bend, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Romagosa Radiation Oncology Center
🇺🇸Lafayette, Louisiana, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Joint Center for Radiation Therapy
🇺🇸Boston, Massachusetts, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
St. Mary's Medical Center
🇺🇸Saginaw, Michigan, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Saint Louis
🇺🇸Saint Louis, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Ozarks Regional
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Saint Joseph Medical Center
🇺🇸Albuquerque, New Mexico, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Kaplan Cancer Center
🇺🇸New York, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Genesee Hospital - Rochester
🇺🇸Rochester, New York, United States
Vassar Brothers Hospital
🇺🇸Poughkeepsie, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
Samaritan Regional Cancer Center
🇺🇸Corvallis, Oregon, United States
Penn State Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
🇺🇸Darby, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Julie and Ben Rogers Cancer Institute
🇺🇸Beaumont, Texas, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Penn State Geisinger Cancer Center
🇺🇸Hershey, Pennsylvania, United States
Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Schiffler Oncology Center
🇺🇸Wheeling, West Virginia, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
South Jersey Hospital - Millville
🇺🇸Millville, New Jersey, United States
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
Elizabeth General Medical Center - West
🇺🇸Elizabeth, New Jersey, United States
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Grand View Hospital
🇺🇸Sellersville, Pennsylvania, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States