Breast Cancer Clinical Trial
Official title:
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer
Verified date | April 2022 |
Source | NSABP Foundation Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer. 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.
Status | Completed |
Enrollment | 4216 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast - Stage 0, I, or II disease - Stage II tumors must be = 3 cm - Gross disease must be unifocal - Microscopic multifocality allowed provided total pathological tumor size is = 3 cm - No proven multicentric carcinoma in more than 1 quadrant or separated by = 4 cm - No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *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 - Prior axillary staging required for patients with invasive breast cancer, including 1 of the following: - Sentinel node biopsy alone (if sentinel node is negative) - Sentinel node biopsy followed by axillary dissection or sampling with = 6 axillary nodes (if sentinel node is positive) - Axillary dissection alone with = 6 axillary nodes - No more than 3 positive axillary nodes - No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension - No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes) - No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor - Must have undergone lumpectomy - Resected margins histologically free of tumor - Re-excision of surgical margins allowed - Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume = 30% based on postoperative pre-randomization CT scan - Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days - No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign - No Paget's disease of the nipple - No history of invasive breast cancer or DCIS - Prior lobular carcinoma in situ treated by surgery alone allowed - No synchronous bilateral invasive or non-invasive breast cancer - Partial breast irradiation deemed technically deliverable by radiation oncologist at a credentialed facility - Must have undergone a history and physical exam within the past 4 months AND a bilateral mammogram within the past 6 months - Hormone receptor status: - Estrogen receptor (ER) status known - Progesterone status known if ER analysis is negative - Marginal or borderline results are considered positive PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Premenopausal or postmenopausal Performance status - Not specified Life expectancy - At least 10 years, excluding diagnosis of breast cancer Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective non-hormonal contraception - No other malignancy within the past 5 years except previously treated carcinoma in situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin cancer - Deemed to be at low risk for recurrence - No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal, or active skin rash - No psychiatric or addictive disorder that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for this malignancy Chemotherapy - No prior chemotherapy for this malignancy - No concurrent chemotherapy during study radiotherapy Endocrine therapy - No prior hormonal therapy for this malignancy unless total duration of hormonal therapy was no more than 28 days before randomization - Concurrent hormonal therapy allowed provided it is not administered during chemotherapy - No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs - No concurrent hormone replacement therapy - No concurrent Femring^® Radiotherapy - No prior radiotherapy for this malignancy - No prior breast or thoracic radiotherapy - No concurrent brachytherapy boosts - No concurrent intensity modulated radiotherapy - No concurrent regional nodal irradiation Surgery - See Disease Characteristics - No prior breast implants - Patients who have had implants removed are eligible Other - No other concurrent anticancer therapy |
Country | Name | City | State |
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Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | London Regional Cancer Program at London Health Sciences Centre | London | Ontario |
Canada | Hopital Notre-Dame du CHUM | Montreal | Quebec |
Canada | Jewish General Hospital - Montreal | Montreal | Quebec |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Royal Victoria Hospital - Montreal | Montreal | Quebec |
Canada | Hopital du Saint-Sacrement - Quebec | Quebec City | Quebec |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | Odette Cancer Centre at Sunnybrook | Toronto | Ontario |
Canada | British Columbia Cancer Agency - Vancouver Island Centre | Victoria | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Ireland | University College Hospital | Galway | |
Israel | Tel-Aviv Sourasky Medical Center | Tel Aviv | |
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 | New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany | New York |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland |
United States | Hope A Women's Cancer Center | Asheville | North Carolina |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Northside Hospital Cancer Center | Atlanta | Georgia |
United States | Auburn Radiation Oncology | Auburn | California |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | St. Agnes Hospital Cancer Center | Baltimore | Maryland |
United States | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine |
United States | Barberton Citizens Hospital | Barberton | Ohio |
United States | Good Shepherd Hospital | Barrington | Illinois |
United States | Memorial Sloan-Kettering Cancer Center - Basking Ridge | Basking Ridge | New Jersey |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | Ochsner Health Center - Bluebonnet | Baton Rouge | Louisiana |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | UPMC Cancer Center at Beaver Medical Center | Beaver | Pennsylvania |
United States | Texas Oncology, PA at Harris Center HEB | Bedford | Texas |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California |
United States | St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
United States | Illinois CancerCare - Bloomington | Bloomington | Illinois |
United States | Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton | Florida |
United States | Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Peninsula Medical Center | Burlingame | 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 | Radiation Oncology Centers - Cameron Park | Cameron Park | California |
United States | Sands Cancer Center | Canandaigua | New York |
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Illinois CancerCare - Canton | Canton | Illinois |
United States | Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California |
United States | Illinois CancerCare - Carthage | Carthage | Illinois |
United States | Sandra L. Maxwell Cancer Center | Cedar City | Utah |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Roper St. Francis Cancer Center at Roper Hospital | Charleston | South Carolina |
United States | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia |
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 | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago | Illinois |
United States | Enloe Cancer Center at Enloe Medical Center | Chico | California |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
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 | Henry Ford Macomb Hospital | Clinton Township | Michigan |
United States | Kootenai Cancer Center - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Memorial Hospital Cancer Center - Colorado Springs | Colorado Springs | Colorado |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | Central Maryland Oncology Center | Columbia | Maryland |
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 | Memorial Sloan-Kettering Cancer Center | Commack | New York |
United States | Cancer Care Center at John Muir Health - Concord Campus | Concord | California |
United States | Payson Center for Cancer Care at Concord Hospital | Concord | New Hampshire |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital | Cooperstown | New York |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | NSMC Cancer Center - Peabody | Danvers | Massachusetts |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | Genesis Regional Cancer Center at Genesis Medical Center | Davenport | Iowa |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia |
United States | Texas Oncology, PA at Texas Cancer Center - Denton South | Denton | Texas |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
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 | Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota |
United States | Northeast Radiation Oncology Center | Dunmore | Pennsylvania |
United States | Duke Cancer Institute | Durham | North Carolina |
United States | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York |
United States | Shore Regional Cancer Center at Memorial Hospital - Easton | Easton | Maryland |
United States | Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Trinitas Comprehensive Cancer Center at Trinitas Hospital | Elizabeth | New Jersey |
United States | Alexian Brothers Radiation Oncology | Elk Grove Village | Illinois |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Regional Cancer Center - Erie | Erie | Pennsylvania |
United States | Willamette Valley Cancer Center - Eugene | Eugene | Oregon |
United States | Illinois CancerCare - Eureka | Eureka | Illinois |
United States | Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire |
United States | North Bay Cancer Center | Fairfield | California |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | McLaren Cancer Institute | Flint | Michigan |
United States | Poudre Valley Radiation Oncology | Fort Collins | Colorado |
United States | Parkview Regional Cancer Center at Parkview Health | Fort Wayne | Indiana |
United States | Radiation Oncology Associates Southwest | Fort Wayne | Indiana |
United States | Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth | Texas |
United States | MetroWest Medical Center - Framingham Union Hospital | Framingham | Massachusetts |
United States | California Cancer Center - Woodward Park Office | Fresno | California |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Illinois CancerCare - Cottage | Galesburg | Illinois |
United States | Illinois CancerCare - Galesburg | Galesburg | Illinois |
United States | Georgetown Memorial Hospital | Georgetown | South Carolina |
United States | Center for Cancer Care at Goshen General Hospital | Goshen | Indiana |
United States | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Three Rivers Community Hospital | Grants Pass | Oregon |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
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 | 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 | PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg | Pennsylvania |
United States | Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford | Connecticut |
United States | Illinois CancerCare - Havana | Havana | Illinois |
United States | Kaiser Permanente Medical Center - Hayward | Hayward | California |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | High Point Regional Hospital | High Point | 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 | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | M. D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Cleveland Clinic Cancer Center | Independence | Ohio |
United States | Central Indiana Cancer Centers - East | Indianapolis | Indiana |
United States | Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana |
United States | St. Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | Baylor Medical Center at Irving | Irving | Texas |
United States | Cayuga Medical Center of Ithaca | Ithaca | New York |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | Baptist Medical Center South | Jacksonville | Florida |
United States | Integrated Community Oncology Network at Southside Cancer Center | Jacksonville | Florida |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Integrated Community Oncology Network | Jacksonville Beach | Florida |
United States | Queens Cancer Center of Queens Hospital | Jamaica | New York |
United States | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kansas City Cancer Centers - North | Kansas City | Missouri |
United States | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska |
United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
United States | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland | Florida |
United States | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan |
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 Comprehensive Cancer Center at Central Maine Medical Center | Lewiston | Maine |
United States | Texas Oncology, PA at Lake Vista Cancer Center | Lewisville | Texas |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Barnabas Medical Center Cancer Center | Livingston | New Jersey |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado |
United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
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 | McKee Medical Center | Loveland | Colorado |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Illinois CancerCare - Macomb | Macomb | Illinois |
United States | Dean Medical Center - Madison | Madison | Wisconsin |
United States | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin |
United States | Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Immanuel St. Joseph's | Mankato | Minnesota |
United States | MedCentral - Mansfield Hospital | Mansfield | Ohio |
United States | Minnesota Oncology - Maplewood | Maplewood | Minnesota |
United States | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
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 Cancer Center at PMCC | Medford | Oregon |
United States | Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin |
United States | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer 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 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
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 | Intercommunity Cancer Center | Monroeville | Pennsylvania |
United States | Community Hospital of the Monterey Peninsula Comprehensive Cancer Center | Monterey | California |
United States | Edward Hospital Cancer Center | Naperville | Illinois |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | Hospital of Saint Raphael | New Haven | Connecticut |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Community Cancer Center | Normal | Illinois |
United States | Illinois CancerCare - Community Cancer Center | Normal | Illinois |
United States | Norristown Regional Cancer Center | Norristown | Pennsylvania |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | Sutter Health - Western Division Cancer Research Group | Novato | California |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | Methodist Estabrook Cancer Center | Omaha | Nebraska |
United States | St. Joseph Hospital Regional Cancer Center - Orange | Orange | California |
United States | Integrated Community Oncology Network - Orange Park | Orange Park | Florida |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Florida Cancer Center - Palatka | Palatka | Florida |
United States | Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California |
United States | Feather River Hospital Cancer Center | Paradise | California |
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 | Arizona Center for Cancer Care - Peoria | Peoria | Arizona |
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 | Illinois CancerCare - Peru | Peru | Illinois |
United States | Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Arizona Oncology Services Foundation | Phoenix | Arizona |
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 | Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | 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 | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Hudson Valley Oncology Associates | Poughkeepsie | New York |
United States | Saint Francis Hospital Cancer Center | Poughkeepsie | New York |
United States | CCOP - Kansas City | Prairie Village | Kansas |
United States | Illinois CancerCare - Princeton | Princeton | Illinois |
United States | Northmain Radiation Oncology | Providence | Rhode Island |
United States | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin |
United States | Cancer Centers of North Carolina - Raleigh | Raleigh | North Carolina |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Redding | California |
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 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Highland Hospital of Rochester | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Lipson Cancer and Blood Center at Rochester General Hospital | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | University Radiation Oncology at Parkridge Hospital | Rochester | New York |
United States | Radiation Oncology Center - Roseville | Roseville | California |
United States | Texas Oncology, PA at Texas Cancer Center Round Rock | Round Rock | Texas |
United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
United States | Mercy General Hospital | Sacramento | California |
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 at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Flagler Cancer Center | Saint Augustine | Florida |
United States | CentraCare Clinic - River Campus | Saint Cloud | Minnesota |
United States | Dixie Regional Medical Center - East Campus | Saint George | Utah |
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 | Salem Hospital Regional Cancer Care Services | Salem | Oregon |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
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 | 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 | Arizona Breast Cancer Specialists | Scottsdale | Arizona |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman | Texas |
United States | Holy Cross Hospital | Silver Spring | Maryland |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta | New Jersey |
United States | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington |
United States | Illinois CancerCare - Spring Valley | Spring Valley | Illinois |
United States | Cancer Institute at St. John's Hospital | Springfield | Illinois |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Stanford Cancer Center | Stanford | California |
United States | Mount Nittany Medical Center | State College | Pennsylvania |
United States | Saint Michael's Hospital Cancer Center | Stevens Point | Wisconsin |
United States | Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas |
United States | Aurora Medical Center | Summit | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Anne Mercy Hospital | Toledo | Ohio |
United States | J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey |
United States | Connecticut Oncology & Hematology - Torrington | Torrington | Connecticut |
United States | St. Francis Regional Cancer 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 | Crozer-Chester Medical Center | Upland | Pennsylvania |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
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 | 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 | Central Dupage Cancer Center | Warrenville | Illinois |
United States | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia |
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 | Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia |
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 | Coastal Carolina Radiation Oncology Center | Wilmington | North Carolina |
United States | Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina |
United States | Minnesota Oncology - Woodbury | Woodbury | Minnesota |
United States | Cleveland Clinic - Wooster | Wooster | Ohio |
United States | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
NSABP Foundation Inc | National Cancer Institute (NCI), Radiation Therapy Oncology Group, Southwest Oncology Group |
United States, Canada, Ireland, Israel,
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.
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 Bi
Bovi J, Qi XS, White J, Li XA. Comparison of three accelerated partial breast irradiation techniques: treatment effectiveness based upon biological models. Radiother Oncol. 2007 Sep;84(3):226-32. Epub 2007 Aug 10. — View Citation
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.
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. — View Citation
Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. — View Citation
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. — View Citation
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 — View Citation
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. Review. — View Citation
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.241 — View Citation
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. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-breast tumor recurrence (IBTR) | every 6 months for 5 years; annually thereafter for up to 10 years | ||
Secondary | Overall survival | time from randomization to death due to any cause assessed up to 15 years | ||
Secondary | Recurrence-free survival | time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years | ||
Secondary | Distant disease-free survival | time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years | ||
Secondary | Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms | measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment | ||
Secondary | Toxicity as assessed by adverse events during treatment | at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years |
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