Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
NCT ID: NCT00003857
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
636 participants
INTERVENTIONAL
1999-12-31
2022-05-20
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
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Detailed Description
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* Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.
* Compare distant disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.
* Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
tamoxifen citrate
adjuvant therapy
Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
tamoxifen citrate
adjuvant therapy
radiation therapy
Interventions
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tamoxifen citrate
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
* Unicentric
* Lesions ≤ 2.5 cm
* Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in \< one third of the involved ducts
* Inked margins ≥ 3 mm
* Clinically node negative
* Non-palpable
* No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
* No bloody nipple discharge
* No more than 12 weeks since prior final surgery (arm II only)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 26 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* No active connective tissue disorders (e.g., lupus or scleroderma)
* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
26 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
NCIC Clinical Trials Group
NETWORK
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Beryl McCormick, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Clifford A. Hudis, MD
Role:
Memorial Sloan Kettering Cancer Center
Barbara L. Smith, MD, PhD
Role: STUDY_CHAIR
Massachusetts General Hospital
Timothy J. Whelan, MD
Role: STUDY_CHAIR
Margaret and Charles Juravinski Cancer Centre
Eileen Rakovitch, MD
Role:
Toronto Sunnybrook Regional Cancer Centre
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
Mount Diablo Regional Cancer Center
Concord, California, United States
North Bay Cancer Center
Fairfield, California, United States
Washington Township Hospital
Fremont, California, United States
Saint Agnes Medical Center
Fresno, California, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
Memorial Medical Center Cancer Services
Modesto, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier, California, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Leeward Radiation Oncology Center
‘Ewa Beach, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Good Shepherd Hospital
Barrington, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States
Regional Cancer Institute at Bloomington Hospital
Bloomington, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Stormont-Vail Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Cancer Treatment Center for Southern Kentucky
Bowling Green, Kentucky, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, United States
Central Maine Medical Center
Lewiston, Maine, United States
Maine Medical Center - Bramhall Campus
Portland, Maine, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River, Massachusetts, United States
MetroWest Medical Center - Framingham Union Hospital
Framingham, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Community Cancer Care at Milford Regional Medical Center
Milford, Massachusetts, United States
Caritas Norwood Hospital
Norwood, Massachusetts, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
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
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States
Foote Hospital
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States
MidMichigan Medical Center - Midland
Midland, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth-Douglass Hospital
Dover, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
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
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque, New Mexico, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Long Island College 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
North Shore University Hospital
Manhasset, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States
Trinity Cancer Care Center
Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
St. Joseph Cancer Center at St. Joseph Health Center
Warren, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Three Rivers Community Hospital
Grants Pass, Oregon, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States
Providence Medford Medical Center
Medford, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Wellspan Health
York, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
University of Texas Medical Branch
Galveston, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
St. Francis Hospital
Federal Way, Washington, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Theda Care Cancer Institute
Appleton, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
Columbia St. Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
West Allis Memorial Hospital
West Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Lethbridge Cancer Centre
Lethbridge, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada
Lions Gate Hospital
North Vancouver, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada
Royal Victoria Hospital of Barrie
Barrie, Ontario, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Trillium Health Centre - Mississauga Site
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
North York General Hospital - Ontario
North York, Ontario, Canada
Male Health Centre - Oakville
Oakville, Ontario, Canada
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Algoma Regional Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Scarborough Hospital - General Campus
Scarborough Village, Ontario, Canada
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Male Health Centre - North York
Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Humber River Regional Hospital - Weston
Weston, Ontario, Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
Centre de Sante et de Services Sociaux de Chicoutimi
Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Doctor Leon Richard Oncology Centre
Greenfield Park, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada
Hotel-Dieu de Levis
Lévis, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Hotel Dieu de Montreal
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
Québec, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Regional de Rimouski
Québec, , Canada
Countries
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References
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McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.
McCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Other Identifiers
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CDR0000067020
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-MA26
Identifier Type: -
Identifier Source: secondary_id
CALGB-49801
Identifier Type: -
Identifier Source: secondary_id
NCI-2011-02038
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG-9804
Identifier Type: -
Identifier Source: org_study_id
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