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Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer Clinical research trials and Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer. Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer  Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.
Details: OBJECTIVES: - Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer. - Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients. - Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining. - Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011. OUTLINE: Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology. Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes. All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks. Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually thereafter. PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an additional 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) invasive breast carcinoma diagnosed within 60 days of sentinel lymph node dissection - Cytologic diagnosis suggestive of carcinoma from a fine needle aspiration of a palpable or nonpalpable breast lesion allowed if clinically suspicious for invasive breast carcinoma - Tumor must be amenable to segmental mastectomy (lumpectomy) - No clinically and radiologically identified multicentric disease that is not amenable to a single lumpectomy - No concurrent bilateral invasive breast malignancies - No tumors in the medial hemisphere of the breast that show complete absence of drainage to the axilla by lymphoscintigram - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Over 18 Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - No renal disease that would increase surgical risk Cardiovascular: - No cardiovascular disease that would increase surgical risk Other: - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or curatively treated lobular carcinoma in situ of the ipsilateral or contralateral breast with a low risk of recurrence - No other nonmalignant systemic disease that would increase surgical risk - No active connective tissue disorders - Able to undergo and have access to radiotherapy - Physically able to undergo bilateral anterior iliac crest bone marrow aspiration - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for invasive breast cancer Endocrine therapy: - No prior estrogen-receptor antagonists (e.g., tamoxifen) or selective estrogen-receptor modulators (e.g., raloxifene) for invasive breast cancer Radiotherapy: - Not specified Surgery: - See Disease Characteristics - No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph nodes or treatment of hidradenitis) - No pre-pectoral breast implant - Subpectoral implant allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArmandoGiuliano, Study Chair, John Wayne Cancer Institute
St. Elizabeth's Hospital
Belleville, Illinois, 62220-1998
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United States
Martin Memorial Cancer Medical Center
Stuart, Florida, 34995
United States
Lutheran Medical Center
Brooklyn, New York, 11220
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1228
United States
Baptist Hospital
Nashville, Tennessee, 37236
United States
Texas Cancer Center at Brackenridge Hospital
Austin, Texas, 78701
United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027
United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
United States
Washington Regional Medical Center
Fayetteville, Arkansas, 72703
United States
Woman's Hospital
Baton Rouge, Louisiana, 70815
United States
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
Zale Lipshy University Hospital
Dallas, Texas, 75235-7786
United States
Methodist Hospital
Houston, Texas, 77030
United States
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, 72205-5331
United States
Singing River Hospital
Pascagoula, Mississippi, 39581
United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
Huntington Memorial Hospital
Pasadena, California, 91109-7013
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, 90027
United States
Lester E. Cox Medical Centers
Springfield, Missouri, 65807-1988
United States
Durham Regional Hospital
Durham, North Carolina, 27704-2763
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Northwestern University Medical Center
Chicago, Illinois, 60611
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
St. Francis Medical Center
Honolulu, Hawaii, 96817
United States
Carilion New River Valley Medical Center
Christiansburg, Virginia, 24073
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-2500
United States
York Cancer Center
York, Pennsylvania, 17403
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Benedictine Hospital
Kingston, New York, 12401
United States
Lakeland Regional Medical Center
Lakeland, Florida, 33804
United States
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
United States
Cork University Hospital
Cork, ,
Ireland
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Carilion Health System - Cancer Center of Western Virginia
Roanoke, Virginia, 24033
United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439-8066
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Kingston Hospital
Kingston, New York, 12401-4692
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Norton Healthcare System
Louisville, Kentucky, 40202-5070
United States
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, 49546
United States
Donald N. Sharp Memorial Community Hospital
San Diego, California, 92123
United States
Park Nicollet Clinic
St. Louis Park, Minnesota, 55416
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Bayfront Medical Center
Saint Petersburg, Florida, 33701
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Saint Anthony Memorial Health Center - Michigan City Campus
Michigan City, Indiana, 46360
United States
Kaiser Permanente Medical Center
Honolulu, Hawaii, 96819
United States
Columbia Lewis-Gale Medical Center
Salem, Virginia, 24153
United States
Sacred Heart Hospital
Allentown, Pennsylvania, 18102
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Belleville Memorial Hospital
Belleville, Illinois, 62226-5399
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
St. Vincent's University Hospital
Dublin, , 4
Ireland
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
St. Luke's Regional Medical Center
Boise, Idaho, 83712
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, 48322
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0542
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
Columbia Regional Hospital
Columbia, Missouri, 65201
United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215-5166
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
McLaren Regional Cancer Center
Flint, Michigan, 48432
United States
DeKalb Medical Center, Inc.
Decatur, Georgia, 30033
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
United States
St. Paul University Hospital
Dallas, Texas, 75235
United States
Little Company of Mary Hospital - Evergreen Park
Evergreen Park, Illinois, 60805-2746
United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70821-2511
United States
Baptist Health Medical Center
Little Rock, Arkansas, 72205-7200
United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York City, New York, 10019
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53201-0342
United States
Watson Clinic
Lakeland, Florida, 33805
United States
Central Baptist Hospital
Lexington, Kentucky, 40503-9985
United States
Ben Taub General Hospital
Houston, Texas, 77030
United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
St. Joseph Hospital - Orange
Orange, California, 92868-3849
United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-3955
United States
Toledo Hospital
Toledo, Ohio, 43606
United States
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Providence Hospital - Mobile AL
Mobile, Alabama, 36685
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401
United States
Summit Medical Center
Oakland, California, 94609
United States
Morton Plant Mease Health Care
Clearwater, Florida, 33756
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
Highland Hospital of Rochester
Rochester, New York, 14620
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
United States
Additional Information:
Study ID Numbers: CDR0000067017; ACOSOG-Z0010,GUMC-00152
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003854
Other Stage 1 Breast Cancer Studies:
1. Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
2. Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer and Positive Axillary Lymph Nodes
3. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
4. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
5. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
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Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
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