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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003855 |
Purpose
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.
PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node |
| Estimated Enrollment: | 1900 |
| Study Start Date: | April 1999 |
OBJECTIVES:
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.
Patients are followed at 30 days, at 6, 12, 18, 30, and 36 months, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for this study within 3.8 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I or IIA (T1 or T2, N0, M0) invasive breast carcinoma amenable to lumpectomy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
No pre-pectoral breast implant
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36640-0460 | |
| Providence Cancer Center | |
| Mobile, Alabama, United States, 36608 | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Arkansas | |
| Washington Regional Medical Center | |
| Fayetteville, Arkansas, United States, 72703 | |
| Baptist Health Medical Center | |
| Little Rock, Arkansas, United States, 72205-7200 | |
| St. Vincent Doctors Doctors Hospital | |
| Little Rock, Arkansas, United States, 72205-5331 | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Arrowhead Regional Medical Center | |
| Colton, California, United States, 92324-1819 | |
| Sonoma Valley Hospital | |
| Sonoma, California, United States, 95476 | |
| Huntington Cancer Center at Huntington Hospital | |
| Pasadena, California, United States, 91105 | |
| John Wayne Cancer Institute at Saint John's Health Center | |
| Santa Monica, California, United States, 90404 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Mercy San Juan Hospital | |
| Carmichael, California, United States, 95608 | |
| Mount Diablo Regional Cancer Center | |
| Concord, California, United States, 94524-4110 | |
| Palo Alto Medical Foundation | |
| Palo Alto, California, United States, 94301 | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| Shasta Regional Medical Center | |
| Redding, California, United States, 96001-0853 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| St. Joseph Hospital Regional Cancer Center - Orange | |
| Orange, California, United States, 92868-3849 | |
| St. Joseph's Regional Cancer Center | |
| Stockton, California, United States, 95204 | |
| Summit Medical Center | |
| Oakland, California, United States, 94609 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33804-1057 | |
| Martin Memorial Cancer Center | |
| Stuart, Florida, United States, 34995-9010 | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| Watson Clinic | |
| Lakeland, Florida, United States, 33805 | |
| United States, Georgia | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Albany, Georgia, United States, 31701 | |
| Phoebe Cancer Center at Phoebe Putney Memorial Hospital | |
| Albany, Georgia, United States, 31702 | |
| Surgical Oncology of Northeast Georgia | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Hawaii | |
| Kaiser Permanente Medical Center | |
| Honolulu, Hawaii, United States, 96819 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Idaho | |
| St. Luke's Regional Medical Center | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Alexian Brothers Medical Center | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Belleville Memorial Hospital | |
| Belleville, Illinois, United States, 62226-5399 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201 | |
| John H. Stroger, Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612-9985 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| St. Elizabeth's Hospital | |
| Belleville, Illinois, United States, 62220-1998 | |
| United States, Indiana | |
| Deaconess Hospital | |
| Evansville, Indiana, United States, 47747 | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| St. Mary's Medical Center | |
| Evansville, Indiana, United States, 47750 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503-9985 | |
| Norton Healthcare Cancer Center | |
| Louisville, Kentucky, United States, 40202-5070 | |
| United States, Louisiana | |
| Baton Rouge General Regional Cancer Center | |
| Baton Rouge, Louisiana, United States, 70821-2511 | |
| Woman's Hospital | |
| Baton Rouge, Louisiana, United States, 70815 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Fallon Clinic at Worcester Medical Center | |
| Worcester, Massachusetts, United States, 01608 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Butterworth Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| Genesys Regional Medical Center | |
| Grand Blanc, Michigan, United States, 48439-8066 | |
| Great Lakes Cancer Institute - McLaren | |
| Flint, Michigan, United States, 48532 | |
| Henry Ford Medical Center - West Bloomfield | |
| West Bloomfield, Michigan, United States, 48322 | |
| Josephine Ford Cancer Center at Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Spectrum Health - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| Spectrum Health Downtown Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0001 | |
| United States, Minnesota | |
| Park Nicollet Clinic | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| Saint Paul, Minnesota, United States, 55102 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler Air Force Base | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| Regional Cancer Center at Singing River Hospital | |
| Pascagoula, Mississippi, United States, 39581 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807-1988 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| St. Louis University Hospital Cancer Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Southern New Hampshire Medical Center | |
| Nashua, New Hampshire, United States, 03061-2014 | |
| United States, New Jersey | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | |
| Marlton, New Jersey, United States, 08053 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962-1956 | |
| United States, New York | |
| Comprehensive Cancer Center at Our Lady of Mercy Medical Center | |
| Bronx, New York, United States, 10466 | |
| Fern Feldman Anolick Breast Center at Benedictine Hospital | |
| Kingston, New York, United States, 12401 | |
| Highland Hospital of Rochester | |
| Rochester, New York, United States, 14620 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Kingston Hospital | |
| Kingston, New York, United States, 12401-4692 | |
| Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital | |
| Cooperstown, New York, United States, 13326 | |
| Lutheran Medical Center | |
| Brooklyn, New York, United States, 11220 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021-4885 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Hope A Women's Cancer Center | |
| Asheville, North Carolina, United States, 28816 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Flower Hospital - ProMedica Health System | |
| Sylvania, Ohio, United States, 43560 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406-1891 | |
| Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044-4898 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Tri-Health Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 90027 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| United States, Oregon | |
| Kaiser Permanente Medical Office - Mother Joseph Plaza | |
| Portland, Oregon, United States, 97225 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| UPMC Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Easton Hospital | |
| Easton, Pennsylvania, United States, 18042 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18105-1556 | |
| Mercy Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Sacred Heart Hospital | |
| Allentown, Pennsylvania, United States, 18102 | |
| St. Luke's Hospital Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Williamsport Hospital | |
| Williamsport, Pennsylvania, United States, 17701-1995 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Dakota | |
| Avera Sacred Heart Hospital | |
| Yankton, South Dakota, United States, 57078 | |
| United States, Tennessee | |
| Baptist Cancer Institute at Baptist Memorial Hospital - Memphis | |
| Memphis, Tennessee, United States, 38120 | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6860 | |
| Sarah Cannon Cancer Center at Centennial Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| Baptist Hospital | |
| Nashville, Tennessee, United States, 37236 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Doctor's Hospital of Laredo | |
| Laredo, Texas, United States, 78045 | |
| Zale Lipshy University Hospital | |
| Dallas, Texas, United States, 75235-7707 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Parkland Health and Hospital System | |
| Dallas, Texas, United States, 75235-7786 | |
| Seton Shivers Cancer Program at Brackenridge Hospital | |
| Austin, Texas, United States, 78701 | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390-9155 | |
| Southwest Cancer and Research Center at University Medical Center | |
| Lubbock, Texas, United States, 79415-3364 | |
| St. Paul University Hospital | |
| Dallas, Texas, United States, 75235 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0542 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| United States, Utah | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center | |
| Saint George, Utah, United States, 84770 | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84132 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Carilion Health System - Cancer Center of Western Virginia | |
| Roanoke, Virginia, United States, 24033 | |
| Carilion New River Valley Medical Center | |
| Christiansburg, Virginia, United States, 24073 | |
| INOVA Fair Oaks Hospital | |
| Fairfax, Virginia, United States, 22033 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| United States, Washington | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98122-4307 | |
| United States, West Virginia | |
| West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506-9300 | |
| United States, Wisconsin | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-7375 | |
| Vince Lombardi Cancer Clinic at St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215-5166 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Ireland | |
| Cork University Hospital | |
| Cork, Ireland | |
| St. Vincent's University Hospital | |
| Dublin, Ireland, 4 | |
| Study Chair: | Armando E. Giuliano, MD | John Wayne Cancer Institute at Saint John's Health Center |
More Information
| Study ID Numbers: | CDR0000067018, ACOSOG-Z0011, GUMC-00153 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003855 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |