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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, Inc. Ft. Myers FL
Baptist Cancer Institute CCOP Memphis TN
Baptist Hospital of East Tennessee Knoxville TN
Baptist Hospital of Miami Miami FL
Bay Area Tumor Institute CCOP Oakland CA
Bayfront Cancer Care Center St. Petersburg FL
Beaumont CCOP Royal Oak MI
Beth Israel Medical Center New York NY
Cancer Research for the Ozarks CCOP Springfield MO
Centre Hospitalier de l`Université de Montréal-Notre Dame Montreal Quebec
Cleveland Clinic Foundation Cleveland OH
Colorado Cancer Research Program Denver CO
Dayton CCOP Kettering OH
Deaconess Medical Center Spokane WA
Dixie Medical Cancer Center East St. George UT
Florida Oncology Center Winter Park FL
Gulf Coast Cancer Treatment Center Panama City FL
Holy Cross Hospital Inc. Fort Lauderdale FL
Joe Arrington Cancer Research & Treatment Center Lubbock TX
Jupiter Medical Center Jupiter FL
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
Lifespan Providence RI
Medical College of Wisconsin Milwaukee WI
Memorial Hospital Colorado Springs CO
Methodist Medical Center of Illinois Peoria IL
Montana Cancer Consortium CCOP Billings MT
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
New York Methodist Hospital Brooklyn NY
Northern Indiana Cancer Research Consortium CCOP South Bend IN
Northwest Community Clinical Oncology Program Tacoma WA
Ochsner Clinic CCOP New Orleans LA
Radiation Oncology Associates of Albuquerque Albuquerque NM
Regional Hospital of Scranton Scranton PA
Roswell Park Cancer Institute Buffalo NY
Sanford Roger Maris Cancer Center Fargo ND
St. Louis University Hospital St. Louis MO
St. Mary`s Medical Center Saginaw MI
St. Vincent Regional Cancer Center CCOP Green Bay WI
Swedish Cancer Institute Seattle WA
Tulane University Medical Center New Orleans LA
University of Alabama at Birmingham Medical Center Birmingham AL
University of Colorado Denver Aurora CO
University of South Alabama Cancer Center CCOP Mobile AL
University of Texas Southwestern Medical School Dallas TX
University of Texas-MD Anderson Cancer Center Houston TX
Virginia Commonwealth University Richmond VA
Virginia Mason CCOP Seattle WA
Wake Forest University Baptist Medical Center Winston-Salem NC
Washington University St. Louis MO
Yakima Valley Memorial Hospital Yakima WA
Updated: 11/21/2013

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