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RTOG 9517 Protocol Information

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A Phase I/II Trial to Evaluate Brachytherapy as the Sole Method of Radiation Therapy for Stage I and II Breast Carcinoma
Protocol Documents
Current Version Date: 2/14/2000
Principal Investigator: Robert R. Kuske, M.D.
Primary Objective:

This study will evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local control rate of brachytherapy when used as the sole method of radiation therapy for patients with stage I and II (<= 3 cm) carcinoma of the breast (non-lobular histology) treated with tylectomy, with histologically assessed negative surgical margins, less than 4 positive nodes at axillary dissection, and without extra-capsular nodal extension or extensive intraductal component (EIC) by the Harvard definition

Patient Population:

Invasive ductal, medullary, papillary, colloid (mucinous), tubular histologies
Stages T1, T2, (lesions <= 3 cm) N0, N1 (up to 3 metastatic axillary lymph nodes with no extracapsular nodal extension [a minimum of 6 nodes in specimen], or a negative sentinel node is acceptable), M0
Six surgical clips placed at time of tylectomy to delineate target volume.
Unifocal breast cancer (single focus which can be encompassed by one tylectomy)
Unilateral breast cancer; no synchronous or previous contralateral breast cancer
Negative or close but negative microscopically-assessed surgical margins (see Section 10.6)
No extensive intraductal component (see Section 3.2.16)
No collagen vascular disease (see Section 3.2.7)
No known unresected residual carcinoma; no diffuse suspicious microcalcifications
No prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer if continuously diseasefree
Negative post-tylectomy mammogram if cancer presented with malignancy-associated microcalcifications

Target Accrual: 92
Current Accrual: 100
Status: Terminated
Date: 11/5/2013
Participating Sites:
21st Century Oncology Ft. Myers FL
Baptist Cancer Institute CCOP Memphis TN
Baptist Hospital of East Tennessee Knoxville TN
Bay Area Tumor Institute Oakland CA
Bayfront Cancer Care Center St. Petersburg FL
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Cleveland Clinic Foundation Cleveland OH
Colorado Cancer Research Program CCOP Denver CO
Covenant Medical Center-Lakeside Lubbock TX
Dayton CCOP Kettering OH
Deaconess Medical Center Spokane WA
Dixie Medical Center Regional Cancer Center East St. George UT
Florida Oncology Center Winter Park FL
Froedtert and the Medical College of Wisconsin Milwaukee WI
Gulf Coast Cancer Treatment Center Panama City FL
Holy Cross Hospital Fort Lauderdale FL
Jupiter Medical Center Jupiter FL
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
Lifespan Providence RI
M D Anderson Cancer Center Houston TX
Methodist Medical Center of Illinois Peoria IL
Miami Cancer Institute Miami FL
Montana Cancer Consortium CCOP Billings MT
Mount Sinai Medical Center Miami Beach FL
Mount Sinai Union Square New York NY
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northern Indiana Cancer Research Consortium South Bend IN
Northwest Community Clinical Oncology Program Tacoma WA
Ochsner Medical Center Jefferson New Orleans LA
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Radiation Oncology Associates of Albuquerque Albuquerque NM
Regional Hospital of Scranton Scranton PA
Roswell Park Cancer Institute Buffalo NY
Saint Louis University Hospital St. Louis MO
Saint Mary's of Michigan Saginaw MI
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Sanford Roger Maris Cancer Center Fargo ND
Swedish Medical Center-First Hill Seattle WA
Tulane University Health Sciences Center New Orleans LA
UCHealth Memorial Hospital Central Colorado Springs CO
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Colorado Hospital Aurora CO
University of South Alabama Mobile AL
University of Texas Southwestern Medical School Dallas TX
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virginia Mason CCOP Seattle WA
Wake Forest University Health Sciences Winston-Salem NC
Washington University School of Medicine St. Louis MO
William Beaumont Hospital-Royal Oak Royal Oak MI
Updated: 11/21/2013

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