Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
NCT ID: NCT00002873
Last Updated: 2013-07-19
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
1997-05-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer.
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Detailed Description
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OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery. All patients receive brachytherapy to the target volume (as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for dose distribution to five planes. Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs low-dose rate) over 2 years.
Conditions
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Study Design
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TREATMENT
Interventions
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brachytherapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No collagen vascular disease with a c-reactive protein level above normal or with an active skin rash (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) No coexisting medical condition that reduces life expectancy to less than 2 years No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for breast cancer Planned chemotherapy may begin at least 2 weeks after removal of brachytherapy catheters Endocrine therapy: Concurrent tamoxifen permitted Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Robert R. Kuske, MD
Role: STUDY_CHAIR
Ochsner Cancer Institute at Ochsner Clinic Foundation
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
Urology Associates - Mobile AL
Mobile, Alabama, United States
MBCCOP - University of South Alabama
Mobile, Alabama, United States
Alabama Oncology, LLC
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, United States
Providence Cancer Therapy Center
Anchorage, Alaska, United States
Arizona Cancer Center
Tucson, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Mount Diablo Medical Center
Concord, California, United States
Beckman Research Institute, City of Hope
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Saint Agnes Cancer Center
Fresno, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Cancer Care Center
Pomona, California, United States
Mercy Medical Center - Redding
Redding, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Santa Cruz Radiation Oncology Medical Group, Inc.
Santa Cruz, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Stanford University
Stanford, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Radiation Oncology Center - Walnut Creek
Walnut Creek, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Lykes Center for Radiation Therapy
Clearwater, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States
University of Florida Health Science Center
Gainesville, Florida, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Radiation Oncology Group
Orange Park, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
West Florida Cancer Institute - Pensacola
Pensacola, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. John's Medical Center
Anderson, Indiana, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
St. Joseph's Radiation Oncology Center
South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Medical Center at Bowling Green
Bowling Green, Kentucky, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Louisville Radiation Oncology
Louisville, Kentucky, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States
Western Baptist Hospital
Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Anne Arundel Oncology Center
Annapolis, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Joint Center for Radiation Therapy
Boston, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
St. Mary's Medical Center
Saginaw, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Ozarks Regional
Springfield, Missouri, United States
Veterans Affairs Medical Center - Saint Louis
St Louis, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Elizabeth General Medical Center - West
Elizabeth, New Jersey, United States
South Jersey Hospital - Millville
Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Kaplan Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Vassar Brothers Hospital
Poughkeepsie, New York, United States
Genesee Hospital - Rochester
Rochester, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States
UNI-MED Medical Center
Minot, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Samaritan Regional Cancer Center
Corvallis, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Penn State Geisinger Medical Center
Danville, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States
Allegheny University Hospitals- Hahnemann
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States
Bayshore Medical Center
Pasadena, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States
Green Mountain Oncology Group
Rutland, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Baptist Hospital
Lynchburg, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Swedish Hospital Tumor Institute
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Schiffler Oncology Center
Wheeling, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, United States
Columbia Hospital
Milwaukee, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Arthur DW, Winter K, Kuske RR, Bolton J, Rabinovitch R, White J, Hanson WF, Wilenzick RM, McCormick B. A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):467-73. doi: 10.1016/j.ijrobp.2007.12.056. Epub 2008 Mar 4.
Ibbott GS, Hanson WF, O'Meara E, Kuske RR, Arthur D, Rabinovitch R, White J, Wilenzick RM, Harris I, Tailor RC. Dose specification and quality assurance of radiation therapy oncology group protocol 95-17; a cooperative group study of iridium-192 breast implants as sole therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1572-8. doi: 10.1016/j.ijrobp.2007.08.011.
Rabinovitch R, Winter K, Kuske R, Bolton J, Arthur D, Scroggins T, Vicini F, McCormick B, White J. RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis. Brachytherapy. 2014 Jan-Feb;13(1):17-22. doi: 10.1016/j.brachy.2013.08.002. Epub 2013 Sep 14.
Kuske RR, Winter K, Arthur DW, et al.: A phase II trial of brachytherapy alone following lumpectomy for stage I or II breast cancer: initial outcomes of RTOG 9517. [Abstract] J Clin Oncol 22 (Suppl 14): A-565, 18s, 2004.
Kuske RR, Winter K, Arthur D, et al.: A phase I/II trial of brachytherapy alone following lumpectomy for select breast cancer: toxicity analysis of Radiation Therapy Oncology Group 95-17. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-151, 87, 2002.
Other Identifiers
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CDR0000065157
Identifier Type: -
Identifier Source: secondary_id
RTOG-9517
Identifier Type: -
Identifier Source: org_study_id
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