Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
NCT ID: NCT00103181
Last Updated: 2022-04-14
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
NA
4216 participants
INTERVENTIONAL
2005-03-31
2018-08-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
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Detailed Description
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Primary
* Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy.
Secondary
* Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
* Compare the cosmetic result in patients treated with these regimens.
* Compare fatigue and treatment-related symptoms in patients treated with these regimens.
* Compare perceived convenience of care in patients treated with these regimens.
* Compare acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ \[DCIS\] only vs invasive and node negative vs invasive with 1-3 positive nodes), menopausal status (premenopausal vs postmenopausal), hormone receptor status (estrogen receptor \[ER\]-positive and/or progesterone receptor \[PR\]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. (Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006.)
* Group 1: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks.
* Group 2: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by multi-catheter brachytherapy, single-entry intracavitary brachytherapy, or 3-D conformal radiotherapy.
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician. Patients with ER-positive or PR-positive tumors may also receive hormonal therapy, beginning 3-12 weeks after completion of adjuvant chemotherapy (or before, during, or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and continuing for at least 5 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 4.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: WBI
Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
whole breast irradiation
Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
Group 2: PBI
Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by intracavitary brachytherapy, MammoSite or other single-entry intracavitary device, or 3-dimensional conformal accelerated partial breast irradiation.
3-dimensional conformal accelerated partial breast irradiation
brachytherapy
MammoSite or other single-entry intracavitary device
Interventions
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3-dimensional conformal accelerated partial breast irradiation
brachytherapy
whole breast irradiation
Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
MammoSite or other single-entry intracavitary device
Eligibility Criteria
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Inclusion Criteria
* No other concurrent anticancer therapy
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Arizona Breast Cancer Specialists
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Auburn Radiation Oncology
Auburn, California, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
North Bay Cancer Center
Fairfield, California, United States
California Cancer Center - Woodward Park Office
Fresno, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, United States
Sutter Health - Western Division Cancer Research Group
Novato, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Feather River Hospital Cancer Center
Paradise, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
Mercy Regional Cancer Center at Mercy Medical Center
Redding, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States
Sharp Memorial Hospital Cancer Center
San Diego, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
Stanford Cancer Center
Stanford, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Sutter Solano Medical Center
Vallejo, 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
Aurora Presbyterian Hospital
Aurora, Colorado, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Connecticut Oncology & Hematology - Torrington
Torrington, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States
Florida Cancer Center - Palatka
Palatka, Florida, United States
Flagler Cancer Center
Saint Augustine, Florida, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, 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
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Illinois CancerCare - Cottage
Galesburg, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
OSF Holy Family Medical Center
Monmouth, Illinois, United States
Edward Hospital Cancer Center
Naperville, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
OSF St. Francis Medical Center
Peoria, 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
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Central Dupage Cancer Center
Warrenville, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
CCOP - Kansas City
Prairie Village, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Ochsner Health Center - Bluebonnet
Baton Rouge, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States
Central Maryland Oncology Center
Columbia, Maryland, United States
Shore Regional Cancer Center at Memorial Hospital - Easton
Easton, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
NSMC Cancer Center - Peabody
Danvers, Massachusetts, United States
MetroWest Medical Center - Framingham Union Hospital
Framingham, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
McLaren Cancer Institute
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, 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
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
MeritCare Bemidji
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
St. Luke's Hospital Cancer Care 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
Mankato, Minnesota, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
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
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Billings Clinic - Downtown
Billings, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States
Saint Mary's Regional Medical Center
Reno, Nevada, United States
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, 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
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States
Trinitas Comprehensive Cancer Center at Trinitas Hospital
Elizabeth, New Jersey, United States
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood, New Jersey, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, 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
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
St. Francis Regional Cancer Center
Trenton, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Sands Cancer Center
Canandaigua, New York, United States
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Cayuga Medical Center of Ithaca
Ithaca, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States
Saint Francis Hospital Cancer Center
Poughkeepsie, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States
University Radiation Oncology at Parkridge Hospital
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Hope A Women's Cancer Center
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Cancer Institute
Durham, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States
Coastal Carolina Radiation Oncology Center
Wilmington, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
MeritCare Broadway
Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Cleveland Clinic Cancer Center
Independence, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, 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 Cancer Center at PMCC
Medford, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & 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 and Children's Hospital
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States
Regional Cancer Center - Erie
Erie, Pennsylvania, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States
Intercommunity Cancer Center
Monroeville, Pennsylvania, United States
Norristown Regional Cancer Center
Norristown, Pennsylvania, United States
Drexel University College of Medicine - Center City Hahnemann Campus
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Northmain Radiation Oncology
Providence, Rhode Island, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Georgetown Memorial Hospital
Georgetown, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Baylor Medical Center at Irving
Irving, Texas, United States
Texas Oncology, PA at Lake Vista Cancer Center
Lewisville, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Texas Oncology, PA at Texas Cancer Center Round Rock
Round Rock, Texas, United States
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States
Val and Ann Browning Cancer Center at 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
Huntsman Cancer Institute at University of Utah
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
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, 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
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States
Dean Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States
Aurora Medical Center
Summit, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
West Allis Memorial Hospital
West Allis, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
Québec, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
University College Hospital
Galway, , Ireland
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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References
Explore related publications, articles, or registry entries linked to this study.
Croshaw R, Kim Y, Lappinen E, Julian T, Trombetta M. Avoiding mastectomy: accelerated partial breast irradiation for breast cancer patients with pacemakers or defibrillators. Ann Surg Oncol. 2011 Nov;18(12):3500-5. doi: 10.1245/s10434-011-1784-2. Epub 2011 May 24.
Hasan Y, Kim L, Wloch J, Chi Y, Liang J, Martinez A, Yan D, Vicini F. Comparison of planned versus actual dose delivered for external beam accelerated partial breast irradiation using cone-beam CT and deformable registration. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1473-6. doi: 10.1016/j.ijrobp.2010.04.013. Epub 2010 Jul 23.
Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
Kainz K, White J, Herman J, Li XA. Investigation of helical tomotherapy for partial-breast irradiation of prone-positioned patients. Int J Radiat Oncol Biol Phys. 2009 May 1;74(1):275-82. doi: 10.1016/j.ijrobp.2008.11.028.
Langen KM, Buchholz DJ, Burch DR, Burkavage R, Limaye AU, Meeks SL, Kupelian PA, Ruchala KJ, Haimerl J, Henderson D, Olivera GH. Investigation of accelerated partial breast patient alignment and treatment with helical tomotherapy unit. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1272-80. doi: 10.1016/j.ijrobp.2007.11.019. Epub 2008 Jan 22.
Wojcicka JB, Lasher DE, Malcom R, Fortier G. Clinical and dosimetric experience with MammoSite-based brachytherapy under the RTOG 0413 protocol. J Appl Clin Med Phys. 2007 Oct 24;8(4):176-184. doi: 10.1120/jacmp.v8i4.2654.
Akbari M, Russo SA, Jacobson JS, et al.: Association of women's local treatment decisions with local recurrence risk and life expectancy. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2035, S228-9, 2006.
Burch D, Langen KM, Buchholz D, et al.: Partial breast irradiation with helical tomotherapy using RTOG 0413 planning constraints. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2047, S235-6, 2006.
Hiatt JR, Evans SB, Price LL, Cardarelli GA, Dipetrillo TA, Wazer DE. Dose-modeling study to compare external beam techniques from protocol NSABP B-39/RTOG 0413 for patients with highly unfavorable cardiac anatomy. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1368-74. doi: 10.1016/j.ijrobp.2006.03.060.
Bovi JA, Li XA, White J, et al.: Comparison of three partial breast irradiation techniques: treatment effectiveness based upon biological models. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-1061, S181, 2005.
Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. doi: 10.2217/14796694.1.6.799.
Sanghani M, Wazer DE. Patient selection for NSABP B-39/RTOG 0413: have we posed the right questions in the right way? Brachytherapy. 2007 Apr-Jun;6(2):119-22. doi: 10.1016/j.brachy.2007.01.002. No abstract available.
Julian TB, Costantino JP, Vicini FA, et al.: Early toxicity results with 3D conformal external beam therapy (CEBT) from the NSABP B-39/RTOG 0413 accelerated partial breast irradiation (APBI) trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-1011, 2011.
Jain AK, Vallow LA, Gale AA, Buskirk SJ. Does three-dimensional external beam partial breast irradiation spare lung tissue compared with standard whole breast irradiation? Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):82-8. doi: 10.1016/j.ijrobp.2008.10.041. Epub 2009 Feb 21.
Tendulkar RD, Chellman-Jeffers M, Rybicki LA, Rim A, Kotwal A, Macklis R, Obi BB. Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. Cancer. 2009 Apr 15;115(8):1621-30. doi: 10.1002/cncr.24172.
Patel RR, Christensen ME, Hodge CW, Adkison JB, Das RK. Clinical outcome analysis in "high-risk" versus "low-risk" patients eligible for national surgical adjuvant breast and bowel B-39/radiation therapy oncology group 0413 trial: five-year results. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):970-3. doi: 10.1016/j.ijrobp.2007.12.005.
Al-Hallaq H, Mell L, Advani S, et al.: Magnetic resonance imaging (MRI) identifies multifocal and multicentric disease in breast cancer patients eligible for the NSABP B-39/RTOG 0413 partial breast irradiation (PBI) trial. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1086, S179-S180, 2006.
Ganz PA, Cecchini RS, White JR, Vicini FA, Arthur DW, Rabinovitch RA, Kuske RR, Julian TB, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Bear HD, Germain I, Gustafson GS, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Wolmark N. Quality-of-life outcomes from NRG Oncology NSABP B-39/RTOG 0413: whole-breast irradiation vs accelerated partial-breast irradiation after breast-conserving surgery. J Natl Cancer Inst. 2025 Jan 1;117(1):103-111. doi: 10.1093/jnci/djae219.
Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NSABP-B-39
Identifier Type: -
Identifier Source: secondary_id
RTOG-0413
Identifier Type: -
Identifier Source: secondary_id
SWOG-NSABP-B-39
Identifier Type: -
Identifier Source: secondary_id
NCI-2009-00698
Identifier Type: REGISTRY
Identifier Source: secondary_id
NSABP B-39/RTOG 0413
Identifier Type: -
Identifier Source: org_study_id
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