Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

Breast Cancer Clinical Trial

Official title:

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003857
• Other study ID #: RTOG-9804
• Secondary ID: CDR0000067020CAN
• Status: Completed
• Phase: Phase 3
• Start date: December 1999
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. 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.

Description:

OBJECTIVES: - 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: May 20, 2022
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 26 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma in Situ

Intervention

Drug:
• tamoxifen citrate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital of Barrie	Barrie	Ontario
Canada	William Osler Health Centre	Brampton	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	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Doctor Leon Richard Oncology Centre	Greenfield Park	Quebec
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Centre Hospitalier Regional de Lanaudiere	Joliette	Quebec
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
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	Lethbridge Cancer Centre	Lethbridge	Alberta
Canada	Hotel-Dieu de Levis	Levis	Quebec
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	Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Hotel Dieu de Montreal	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Nanaimo Cancer Clinic at Nanaimo Regional General Hospital	Nanaimo	British Columbia
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Lions Gate Hospital	North Vancouver	British Columbia
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	Centre Hospitalier Regional de Rimouski	Quebec
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Hopital du Saint-Sacrement - Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Algoma Regional Cancer Program at Sault Area Hospital	Sault Sainte Marie	Ontario
Canada	Scarborough Hospital - General Campus	Scarborough	Ontario
Canada	St. Catharines General Hospital at Niagara Health System	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	BCCA - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Cape Breton Cancer Centre	Sydney	Nova Scotia
Canada	Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Male Health Centre - North York	Toronto	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Prostate Centre at Vancouver General Hospital	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	Humber River Regional Hospital - Weston	Weston	Ontario
Canada	Windsor Regional Cancer Centre at Windsor Regional Hospital	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Leeward Radiation Oncology Center	'Ewa Beach	Hawaii
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
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	AnMed Health Cancer Center	Anderson	South Carolina
United States	St. John's Cancer Center at St. John's Medical Center	Anderson	Indiana
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Theda Care Cancer Institute	Appleton	Wisconsin
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Good Shepherd Hospital	Barrington	Illinois
United States	Suburban Hospital	Bethesda	Maryland
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	Regional Cancer Institute at Bloomington Hospital	Bloomington	Indiana
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cancer Treatment Center for Southern Kentucky	Bowling Green	Kentucky
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	Long Island College Hospital	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
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	Martha Jefferson Hospital Cancer Care Center	Charlottesville	Virginia
United States	Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Enloe Cancer Center at Enloe Medical Center	Chico	California
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cancer Treatment Center at Good Samaritan Hospital	Cincinnati	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Palmetto Health South Carolina Cancer Center	Columbia	South Carolina
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Batte Cancer Center at Northeast Medical Center	Concord	North Carolina
United States	Bethke Cancer Center at Emerson Hospital	Concord	Massachusetts
United States	Dartmouth - Hitchcock Concord	Concord	New Hampshire
United States	Mount Diablo Regional Cancer Center	Concord	California
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Seacoast Cancer Center at Wentworth-Douglass Hospital	Dover	New Hampshire
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Easton Regional Cancer Center at Easton Hospital	Easton	Pennsylvania
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	North Bay Cancer Center	Fairfield	California
United States	Hudner Oncology Center at Saint Anne's Hospital	Fall River	Massachusetts
United States	St. Francis Hospital	Federal Way	Washington
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Great Lakes Cancer Institute at McLaren Regional Medical Center	Flint	Michigan
United States	Parkview Regional Cancer Center at Parkview Health	Fort Wayne	Indiana
United States	MetroWest Medical Center - Framingham Union Hospital	Framingham	Massachusetts
United States	Washington Township Hospital	Fremont	California
United States	Saint Agnes Medical Center	Fresno	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
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	Three Rivers Community Hospital	Grants Pass	Oregon
United States	Great Falls Clinic	Great Falls	Montana
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent 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	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital	Greenville	North Carolina
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
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	Saint Joseph's Mercy Cancer Center	Hot Springs	Arkansas
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Hematology Oncology Associates of Eastern Idaho	Idaho Falls	Idaho
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital	Inglewood	California
United States	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan
United States	Foote Hospital	Jackson	Michigan
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington
United States	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	St. Mary Regional Cancer Center	Langhorne	Pennsylvania
United States	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Maine Medical Center	Lewiston	Maine
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County	Madisonville	Kentucky
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	Immanuel St. Joseph's Clinic	Mankato	Minnesota
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey
United States	Upper Michigan Cancer Center at Marquette General Hospital	Marquette	Michigan
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Dubs Cancer Center at Rogue Valley Medical Center	Medford	Oregon
United States	Providence Medford Medical Center	Medford	Oregon
United States	Community Memorial Hospital Cancer Care Center	Menomonee Falls	Wisconsin
United States	Baptist-South Miami Regional Cancer Program	Miami	Florida
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	MidMichigan Medical Center - Midland	Midland	Michigan
United States	Community Cancer Care at Milford Regional Medical Center	Milford	Massachusetts
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	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	Providence Holy Cross Cancer Center	Mission Hills	California
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Memorial Medical Center Cancer Services	Modesto	California
United States	Cottonwood Hospital Medical Center	Murray	Utah
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	Hospital of Saint Raphael	New Haven	Connecticut
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 - Christiana Care Health Services	Newark	Delaware
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Caritas Norwood Hospital	Norwood	Massachusetts
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
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	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Fox Chase-Temple Cancer Center CCOP Research Base	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Mercy Cancer Institute at Mercy Hospital	Pittsburgh	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center	Pomona	California
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	Portland	Oregon
United States	Maine Medical Center - Bramhall Campus	Portland	Maine
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Community Cancer Center at Rutland Regional Medical Center	Rutland	Vermont
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute - Saginaw	Saginaw	Michigan
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan
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	Peninsula Regional Medical Center	Salisbury	Maryland
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania
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	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	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts
United States	Mercy Medical Center	Springfield	Ohio
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	Madigan Army Medical Center - Tacoma	Tacoma	Washington
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	Torrance Memorial Medical Center	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	Fox Chase Cancer Center at St. Francis Medical Center	Trenton	New Jersey
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	St. Joseph Cancer Center at St. Joseph Health Center	Warren	Ohio
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	West Allis Memorial Hospital	West Milwaukee	Wisconsin
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital	Whittier	California
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
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	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

Sponsors (5)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI), NCIC Clinical Trials Group, NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence (e.g., invasive or noninvasive recurrence)		From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Secondary	Overall survival		From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Secondary	Time to distant metastasis		From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Secondary	Invasive local recurrence		From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Secondary	Salvage mastectomy rate		Analysis occurs after all patients have been potentially followed for 5 years.

External Links

•   Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.