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Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer Clinical research trials and Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer. Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , National Cancer Institute (NCI)
Synopsis: RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
Details: OBJECTIVES: - Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative. - Compare the effect of these two regimens on the overall and disease-free survival of these patients. - Compare the morbidity associated with these two regimens in these patients. - Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology. - Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology. - Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons. - Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients. Objectives of quality of life questionnaire in sentinel node-negative patients: - Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens. - Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side. - Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms. All patients receive technetium (Tc 99m) sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium (Tc 99m) sulfur colloid, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector. If a hot spot is not identified, the blue dye is injected after a saline bolus injection. - Arm I: Patients undergo sentinel node resection immediately followed by conventional axillary dissection. - Arm II: Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes. Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection. Patients with cytologically negative sentinel nodes do not undergo axillary dissection. Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection. Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection. Patients with pathologically positive, nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection. Patients with evidence of tumor remaining after surgery undergo a total mastectomy. Quality of life is assessed at baseline, at weeks 1-3, and then every 6 months for 3 years or until recurrence. Patients are followed at 1 and 3 weeks, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following: - Histologically confirmed by core or open biopsy - Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography - Clinically negative lymph nodes - No positive ipsilateral axillary lymph nodes - No prior removal of ipsilateral axillary lymph nodes - No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy - No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude - Tethering or dimpling of the skin or nipple inversion allowed - No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy - No diffuse tumors or multiple malignant tumors in different quadrants of the breast - No other prior breast malignancy except lobular carcinoma in situ - No prior or concurrent breast implants - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - At least 10 years (excluding diagnosis of cancer) Hematopoietic: - Not specified Hepatic: - No hepatic systemic disease Renal: - No renal systemic disease Cardiovascular: - No cardiovascular systemic disease Other: - No prior malignancy within past 5 years except: - Effectively treated squamous cell or basal cell skin cancer - Surgically treated carcinoma in situ of the cervix - Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast - No concurrent psychiatric or addictive disorder PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for this cancer Chemotherapy: - No prior chemotherapy for this cancer, including neoadjuvant chemotherapy Endocrine therapy: - No prior hormonal therapy for this cancer Radiotherapy: - No prior radiotherapy for this cancer Surgery: - See Disease Characteristics - No prior breast reduction surgery - Prior excisional biopsy or lumpectomy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidKrag, Study Chair, Vermont Cancer Center at University of Vermont
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Contact Person 504-585-6450
Jewish Hospital of Cincinnati, Incorporated *Recruiting*
Cincinnati, Ohio, 45236
United States
Recruiting Contact Person 513-686-5434 ext. 5434
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting Contact Person 804-628-1893
Sarasota Memorial Hospital *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Contact Person 941-363-5713
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114
United States
Recruiting Contact Person 402-354-8237
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Contact Person 336-716-6240
Akron City Hospital *Recruiting*
Akron, Ohio, 44312
United States
Recruiting Contact Person 330-375-4221
CCOP - Dayton *Recruiting*
Kettering, Ohio, 45429
United States
Recruiting Contact Person 937-395-8678
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego *Recruiting*
San Diego, California, 92120
United States
Recruiting Contact Person 619-528-5896
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97213
United States
Recruiting Contact Person 503-216-6262
Virginia Oncology Associates - Newport News *Recruiting*
Newport News, Virginia, 23606
United States
Recruiting Contact Person 757-873-9834
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Contact Person 610-645-2680
MBCCOP-Cook County Hospital *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Contact Person 312-864-5204
Eastern Maine Medical Center *Recruiting*
Bangor, Maine, 04401
United States
Recruiting Contact Person 207-973-4274
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5408
United States
Recruiting Contact Person 650-724-1953
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Contact Person 732-235-9659
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting Contact Person 614-488-2118
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Contact Person 808-586-2979
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L-4M1
Canada
Recruiting Contact Person 514-890-8000 ext. 15535
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Contact Person 734-712-5947
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting Contact Person 336-777-3094
Franklin Square Hospital Center *Recruiting*
Baltimore, Maryland, 21237
United States
Recruiting Contact Person 443-777-7962
Halifax Medical Center *Recruiting*
Daytona Beach, Florida, 32114
United States
Recruiting Contact Person 386-254-4211
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Contact Person 406-259-2245
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Contact Person 269-373-7458
Newark Beth Israel Medical Center *Recruiting*
Newark, New Jersey, 07112
United States
Recruiting Contact Person 973-926-3136
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Contact Person 412-359-6526
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Contact Person 801-321-1236
Royal Victoria Hospital - Montreal *Recruiting*
Montreal, Quebec, H3A 1A1
Canada
Recruiting Contact Person 514-843-1572
Jewish General Hospital - Montreal *Recruiting*
Montreal, Quebec, H3T 1E2
Canada
Recruiting Contact Person 514-340-8222, Ext. 5526
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Contact Person 508-856-3215
Geisinger Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Contact Person 570-271-6362
Hartford Hospital *Recruiting*
Hartford, Connecticut, 06102-5037
United States
Recruiting Contact Person 860-545-5363
Puget Sound Oncology Consortium *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Contact Person 206-667-4692
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Contact Person 701-234-6298
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Contact Person 515-244-7586
Creticos Cancer Center at Advocate Illinois Masonic Medical Center *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Contact Person 773-296-5360
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Contact Person 801-585-5162
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36688
United States
Recruiting Contact Person 251-435-3941
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Contact Person 202-806-9122
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Contact Person 305-674-2625
New York Oncology Hematology, P.C. - Albany Regional Cancer Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Contact Person 518-489-2607
Baptist Regional Cancer Institute - Jacksonville *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Contact Person 904-202-7069
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Contact Person 506-648-7758
Michigan State University *Recruiting*
East Lansing, Michigan, 48824
United States
Recruiting Contact Person 517-334-2715
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Contact Person 316-268-5696
St. Mary's Hospital Center *Recruiting*
Montreal, Quebec, H3T 1M5
Canada
Recruiting Contact Person 514-345-3511, Ext. 3378
Aultman Hospital Cancer Center at Aultman Health Foundation *Recruiting*
Canton, Ohio, 44710
United States
Recruiting Contact Person 330-363-3277
Sutter Breast Cancer Group *Recruiting*
Sacramento, California, 95819-5156
United States
Recruiting Contact Person 916-453-5800
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Contact Person 215-955-1562
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Contact Person 210-567-5751
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Contact Person 626-359-8111, Ext. 62340
MBCCOP - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Contact Person 787-763-1296
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting Contact Person 864-560-6812
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Contact Person 313-916-7277
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Contact Person 416-480-6063
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Contact Person 816-823-0555
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting Contact Person 309-636-3605
Loma Linda University Cancer Institute at Loma Linda University Medical Center *Recruiting*
Loma Linda, California, 92354
United States
Recruiting Contact Person 909-558-3375 ext. 33377
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Contact Person 504-568-3307
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Contact Person 802-656-2278
Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46206-1367
United States
Recruiting Contact Person 317-929-6597
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting Contact Person 248-551-6927
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Contact Person 616-391-1230
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Contact Person 305-243-3382
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Contact Person 617-638-8434
Reading Hospital and Medical Center *Recruiting*
Reading, Pennsylvania, 19612-6052
United States
Recruiting Contact Person 610-988-8193
Camcare Health *Recruiting*
Charleston, West Virginia, 25304
United States
Recruiting Contact Person 304-388-9936
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Contact Person 501-686-8274
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Contact Person 418-682-8032
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Contact Person 216-844-4724
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Contact Person 253-403-1461
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075-9975
United States
Recruiting Contact Person 248-424-5337
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Contact Person 416-976-4501 ext. 5836
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Contact Person 574-284-7977
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0502
United States
Recruiting Contact Person 513-584-0207
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Contact Person 414-805-5831
St. Michael's Hospital - Toronto *Recruiting*
Toronto, Ontario, M5B 1W8
Canada
Recruiting Contact Person 416-864-5354
Additional Information:
Study ID Numbers: CDR0000066987; NSABP-B-32
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003830
Other Stage 2 Breast Cancer Studies:
1. Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
2. Medroxyprogesterone in Treating Women With Breast Cancer
3. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
4. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
5. Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
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Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
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