A PHASE I/II TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA
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.
Interventional
Primary Purpose: Treatment
Robert R. Kuske, MD
Study Chair
Ochsner Cancer Institute at Ochsner Clinic Foundation
United States: Federal Government
CDR0000065157
NCT00002873
May 1997
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Arizona Cancer Center | Tucson, Arizona 85724 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Kaplan Cancer Center | New York, New York 10016 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
Hurley Medical Center | Flint, Michigan 48503 |
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Huntsville Hospital System | Huntsville, Alabama 35801 |
MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
Urology Associates - Mobile AL | Mobile, Alabama 36640 |
Alabama Oncology, LLC | Montgomery, Alabama 36106-2801 |
Radiation Oncology Associates of West Alabama | Tuscallosa, Alabama 35401 |
Providence Cancer Therapy Center | Anchorage, Alaska 99508 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Mount Diablo Medical Center | Concord, California 94524-4110 |
California Cancer Center | Fresno, California 93720 |
Saint Agnes Cancer Center | Fresno, California 93720 |
Glendale Memorial Hospital and Health Center | Glendale, California 91204 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Cancer Care Center | Pomona, California 91767 |
Mercy Medical Center - Redding | Redding, California 96099-6009 |
Radiation Oncology Center - Sacramento | Sacramento, California 95816 |
Santa Cruz Radiation Oncology Medical Group, Inc. | Santa Cruz, California 95065 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
Stanford University | Stanford, California 94305 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
Radiation Oncology Center - Walnut Creek | Walnut Creek, California 94598 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
Bridgeport Hospital | Bridgeport, Connecticut 06610 |
Whittingham Cancer Center | Norwalk, Connecticut 06856 |
Lykes Center for Radiation Therapy | Clearwater, Florida 33757-0210 |
Halifax Medical Center | Daytona Beach, Florida 32114 |
Radiation Therapy Associates - Fort Myers | Fort Myers, Florida 33901 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Health First Holmes Regional Medical Center | Melbourne, Florida 32901 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Florida Radiation Oncology Group | Orange Park, Florida 32073 |
Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
West Florida Cancer Institute - Pensacola | Pensacola, Florida 32514 |
Bayfront Medical Center | Saint Petersburg, Florida 33701 |
InterCommunity Cancer Center at Rome | Rome, Georgia 30161 |
South Georgia Medical Center | Valdosta, Georgia 31603 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
St. John's Medical Center | Anderson, Indiana 46016 |
Clarion Health Partners Inc. | Indianapolis, Indiana 46206-1367 |
Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis, Indiana 46219 |
Ball Memorial Hospital | Muncie, Indiana 47303-3499 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
St. Joseph's Radiation Oncology Center | South Bend, Indiana 46617 |
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
Medical Center at Bowling Green | Bowling Green, Kentucky 42102 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Louisville Radiation Oncology | Louisville, Kentucky 40215 |
Merle M. Mahr Cancer Center | Madisonville, Kentucky 42431 |
Western Baptist Hospital | Paducah, Kentucky 42001 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Romagosa Radiation Oncology Center | Lafayette, Louisiana 70501 |
East Jefferson General Hospital | Metairie, Louisiana 70011 |
Maine Medical Center | Portland, Maine 04102 |
Anne Arundel Oncology Center | Annapolis, Maryland 21401 |
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
Harbor Hospital Center | Baltimore, Maryland 21225 |
Radiation Oncology Affiliates of Maryland, P.A. | Baltimore, Maryland 21237 |
Joint Center for Radiation Therapy | Boston, Massachusetts 02215 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
Marquette General Hospital | Marquette, Michigan 49855 |
St. Mary's Medical Center | Saginaw, Michigan 48601 |
Veterans Affairs Medical Center - Saint Louis | Saint Louis, Missouri 63106 |
Mallinckrodt Institute of Radiology | Saint Louis, Missouri 63110 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
John F. Kennedy Medical Center | Edison, New Jersey 08818 |
South Jersey Hospital - Millville | Millville, New Jersey 08332 |
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Community Medical Center | Toms River, New Jersey 08755 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
Saint Joseph Medical Center | Albuquerque, New Mexico 87102 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
Vassar Brothers Hospital | Poughkeepsie, New York 12601 |
Genesee Hospital - Rochester | Rochester, New York 14607 |
New York Medical College | Valhalla, New York 10595 |
Meritcare Roger Maris Cancer Center | Fargo, North Dakota 58122 |
UNI-MED Medical Center | Minot, North Dakota 58701 |
Akron General Medical Center | Akron, Ohio 44302 |
Christ Hospital | Cincinnati, Ohio 45219 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
St. John Medical Center | Tulsa, Oklahoma 74104 |
Samaritan Regional Cancer Center | Corvallis, Oregon 97339 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
Penn State Geisinger Medical Center | Danville, Pennsylvania 17822-2001 |
Mercy Catholic Medical Center, Mercy Fitzgerald Divison | Darby, Pennsylvania 19023 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Penn State Geisinger Cancer Center | Hershey, Pennsylvania 17033 |
Allegheny University Hospitals- Hahnemann | Philadelphia, Pennsylvania 19102-1192 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Veterans Affairs Medical Center - Philadelphia | Philadelphia, Pennsylvania 19104 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
Grand View Hospital | Sellersville, Pennsylvania 18960 |
Wilkes Barre General Hospital | Wilkes-Barre, Pennsylvania 18764 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
York Hospital | York, Pennsylvania 17315 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
Julie and Ben Rogers Cancer Institute | Beaumont, Texas 77701 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
Bayshore Medical Center | Pasadena, Texas 77504 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
Virginia Baptist Hospital | Lynchburg, Virginia 24503 |
Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Schiffler Oncology Center | Wheeling, West Virginia 26003 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Gundersen Lutheran Medical Foundation | La Crosse, Wisconsin 54601 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Southern Wisconsin Radiotherapy Center | Madison, Wisconsin 53713 |
Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
Columbia Hospital | Milwaukee, Wisconsin 53211 |
St. Joseph's Hospital | Milwaukee, Wisconsin 53210 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
Southeastern Wisconsin Regional Cancer Center | Racine, Wisconsin 53405 |
Elizabeth General Medical Center - West | Elizabeth, New Jersey 07201 |
Swedish Hospital Tumor Institute | Seattle, Washington 98104 |
CCOP - Ozarks Regional | Springfield, Missouri 65807 |