RTOG 0319 Protocol Information

A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity For Stage I And II Breast Carcinoma
Protocol Documents
Current Version Date: 9/30/2003
Principal Investigator: Frank A. Vicini, M.D.
Primary Objective:

This study will evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity 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 (> 2 mm), up to 3 nodes positive at axillary dissection or sentinel lymph node biopsy, with no extensive intraductal component (EIC) by the Harvard definition.

Patient Population:

Invasive ductal, medullary, papillary, colloid (mucinous), tubular histologies. AJCC Stage I or II (T1N0, T1N1, T2N0, T2N1); lesion <= 3 cm.


This study has a CTEP status of completed (primary endpoint published). Because CTEP does not process amendments for completed studies, updated contact information for Dr. Frank Vicini, Principal Investigator, is provided below: 

Frank A. Vicini, M.D.
Botsford Cancer Center

27900 Grand River Avenue

Suite 120

Farmington Hills, Michigan 48336


Target Accrual: 46
Current Accrual: 58
Status: Closed to Accrual
Date: 4/30/2004
Participating Sites:
ACR Clinical Research Center Philadelphia PA
Akron City Hospital Akron OH
Albert Einstein Medical Center Philadelphia PA
Allegheny General Hospital Pittsburgh PA
Alta Bates Hospital Comprehensive Cancer Center Berkeley CA
Anne Arundel Medical Center Annapolis MD
Annie Penn Memorial Hospital Reidsville NC
Arizona Oncology - Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
Bay Area Tumor Institute CCOP Oakland CA
Beaumont CCOP Royal Oak MI
California Pacific Medical Center San Francisco CA
Cancer Care Center, Inc Salem OH
Cancer Treatment Center Wooster OH
Centre Hospitalier de l`Université de Montréal-Notre Dame Montreal Quebec
Cleveland Clinic Foundation Cleveland OH
Columbia River CCOP Portland OR
Columbia-Presbyterian Medical Center New York NY
Columbus Community Clinical Oncology Program Columbus OH
Community Memorial Hospital Menomonee Falls WI
Cone Health Cancer Center Greensboro NC
Cross Cancer Institute Edmonton, Alberta
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Cancer Center East St. George UT
East Bay Radiation Oncology Center Castro Valley CA
Forsyth Regional Medical Center Winston Salem NC
Grant Medical Center Columbus OH
Gulf Coast Cancer Treatment Center Panama City FL
Gunderson Clinic La Crosse WI
Henry Ford Hospital Detroit MI
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Holy Cross Hospital Inc. Fort Lauderdale FL
Image-Guided Therapy QA Center (ITC) St. Louis MO
Indiana University Medical Center Indianapolis IN
Intermountain Medical Center Murray UT
Jupiter Medical Center Jupiter FL
L Hotel-Dieu de Quebec Quebec
LDS Hospital Salt Lake City UT
Logan Regional Hospital Logan UT
London Regional Cancer Program London Ontario
Loyola University Chicago Maywood IL
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
McKay-Dee Hospital Ogden UT
McLaren Cancer Institute - Flint Flint MI
Medical College of Wisconsin Milwaukee WI
Memorial Sloan-Kettering Cancer Center New York NY
Methodist Medical Center of Illinois Peoria IL
Mills-Peninsula Health Services San Mateo CA
Missouri Valley Cancer Consortium CCOP Omaha NE
Mobile Infirmary Medical Center Mobile AL
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
Northwestern Memorial Hospital Chicago IL
Ochsner Clinic CCOP New Orleans LA
Penn State University and The Milton S. Hershey Medical Ctr Hershey PA
Radiation Oncology Associates of Albuquerque Albuquerque NM
Radiological Physics Center (RPC) Houston TX
Randolph Hospital Ashboro NC
Rex Cancer Center Raleigh NC
Roswell Park Cancer Institute Buffalo NY
Sandra L. Maxwell Cancer Center Cedar City UT
Scott and White Memorial Hospital Temple TX
Southeast Cancer Control Consortium, Inc., CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
St. Lukes Hospital Bethlehem PA
Sutter Health Western Division Cancer Research Group Novato CA
The Schiffler Cancer Center Wheeling WV
The Wendt Regional Cancer Center of the Finley Hospital Dubuque IA
Thomas Jefferson University Hospital Philadelphia PA
Torrance Memorial Medical Center Torrance CA
University of California Davis Medical Center Sacramento CA
University of Colorado Denver Aurora CO
University of Florida College of Medicine Gainesville FL
University of Florida Health Science Center Jacksonville FL
University of Miami Miller School of Medicine Miami FL
University of Rochester Rochester NY
University of Texas-MD Anderson Cancer Center Houston TX
Utah Cancer Specialists Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Virginia Commonwealth University Richmond VA
Virginia Mason CCOP Seattle WA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Washington University St. Louis MO
Wayne State University-Karmanos Cancer Institute Detroit MI
Western Pennsylvania Hospital Pittsburgh PA
William Beaumont Hospital / Troy Troy MI
Yale University New Haven CT
Updated: 8/6/2014

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