A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
OBJECTIVES:
- Determine whether axillary lymph node dissection (ALND) improves overall survival in
women with stage I or IIA breast cancer.
- Quantify and compare surgical morbidities associated with sentinel lymph node
dissection with or without ALND in these patients.
OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node
dissection, patients are stratified according to age (50 and under vs over 50), estrogen
receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than
1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two
treatment arms.
- Arm I: Patients undergo axillary lymph node dissection involving removal of at least
level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third
supraclavicular field) 5 days a week for a maximum of 7 weeks.
- Arm II: Patients undergo breast radiotherapy only as in arm I. Patients in both arms
may receive adjuvant systemic therapy at the discretion of the treating physician.
Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for
a total of 10 years.
PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for
this study within 3.8 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Armando E. Giuliano, MD
Study Chair
John Wayne Cancer Institute at Saint John's Health Center
United States: Federal Government
CDR0000067018
NCT00003855
April 1999
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
United Hospital | St. Paul, Minnesota 55102 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
Maine Medical Center | Portland, Maine 04102 |
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Evanston Northwestern Health Care - Evanston Hospital | Evanston, Illinois 60201 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Toledo Hospital | Toledo, Ohio 43606 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
Arthur G. James Cancer Hospital at Ohio State University | Columbus, Ohio 43210-1240 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Butterworth Hospital | Grand Rapids, Michigan 49503 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
Summit Medical Center | Oakland, California 94609 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Baylor University Medical Center | Dallas, Texas 75246 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Mount Diablo Regional Cancer Center | Concord, California 94524-4110 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
Palo Alto Medical Foundation | Palo Alto, California 94301 |
St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Miami Valley Hospital | Dayton, Ohio 45409 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
Vince Lombardi Cancer Clinic at St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Washington Regional Medical Center | Fayetteville, Arkansas 72703 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
St. Francis Medical Center | Honolulu, Hawaii 96817 |
Morton Plant Hospital | Clearwater, Florida 33756 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Norton Healthcare Cancer Center | Louisville, Kentucky 40202-5070 |
Huntington Cancer Center at Huntington Hospital | Pasadena, California 91105 |
Alexian Brothers Medical Center | Elk Grove Village, Illinois 60007 |
Tri-Health Good Samaritan Hospital | Cincinnati, Ohio 45220 |
Baptist Health Medical Center | Little Rock, Arkansas 72205-7200 |
St. Vincent Doctors Doctors Hospital | Little Rock, Arkansas 72205-5331 |
Watson Clinic | Lakeland, Florida 33805 |
Kaiser Permanente Medical Center | Honolulu, Hawaii 96819 |
St. Luke's Regional Medical Center | Boise, Idaho 83712 |
Belleville Memorial Hospital | Belleville, Illinois 62226-5399 |
St. Elizabeth's Hospital | Belleville, Illinois 62220-1998 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Henry Ford Medical Center - West Bloomfield | West Bloomfield, Michigan 48322 |
Lutheran Medical Center | Brooklyn, New York 11220 |
Kingston Hospital | Kingston, New York 12401-4692 |
Sacred Heart Hospital | Allentown, Pennsylvania 18102 |
Baptist Hospital | Nashville, Tennessee 37236 |
St. Paul University Hospital | Dallas, Texas 75235 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Carilion New River Valley Medical Center | Christiansburg, Virginia 24073 |
Carilion Health System - Cancer Center of Western Virginia | Roanoke, Virginia 24033 |
Providence Cancer Center | Mobile, Alabama 36608 |
Mercy San Juan Hospital | Carmichael, California 95608 |
Arrowhead Regional Medical Center | Colton, California 92324-1819 |
St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
Shasta Regional Medical Center | Redding, California 96001-0853 |
Sharp Memorial Hospital | San Diego, California 92123 |
John Wayne Cancer Institute at Saint John's Health Center | Santa Monica, California 90404 |
Sonoma Valley Hospital | Sonoma, California 95476 |
St. Joseph's Regional Cancer Center | Stockton, California 95204 |
Martin Memorial Cancer Center | Stuart, Florida 34995-9010 |
Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany, Georgia 31702 |
Albany, Georgia 31701 | |
Surgical Oncology of Northeast Georgia | Gainesville, Georgia 30501 |
Deaconess Hospital | Evansville, Indiana 47747 |
St. Mary's Medical Center | Evansville, Indiana 47750 |
Fallon Clinic at Worcester Medical Center | Worcester, Massachusetts 01608 |
Great Lakes Cancer Institute - McLaren | Flint, Michigan 48532 |
Spectrum Health - Blodgett Campus | Grand Rapids, Michigan 49506 |
Spectrum Health Downtown Campus | Grand Rapids, Michigan 49503 |
Southern New Hampshire Medical Center | Nashua, New Hampshire 03061-2014 |
Comprehensive Cancer Center at Our Lady of Mercy Medical Center | Bronx, New York 10466 |
Fern Feldman Anolick Breast Center at Benedictine Hospital | Kingston, New York 12401 |
Flower Hospital - ProMedica Health System | Sylvania, Ohio 43560 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Kaiser Permanente Medical Office - Mother Joseph Plaza | Portland, Oregon 97225 |
Easton Hospital | Easton, Pennsylvania 18042 |
Williamsport Hospital | Williamsport, Pennsylvania 17701-1995 |
Avera Sacred Heart Hospital | Yankton, South Dakota 57078 |
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis | Memphis, Tennessee 38120 |
Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
Seton Shivers Cancer Program at Brackenridge Hospital | Austin, Texas 78701 |
Parkland Health and Hospital System | Dallas, Texas 75235-7786 |
Southwest Cancer and Research Center at University Medical Center | Lubbock, Texas 79415-3364 |
INOVA Fair Oaks Hospital | Fairfax, Virginia 22033 |