A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
OBJECTIVES:
Primary
- To determine whether an accelerated course of hypofractionated whole-breast irradiation
(WBI) including a concomitant boost to the tumor bed in 15 fractions following
lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI
with a sequential boost following lumpectomy for early-stage breast cancer patients.
Secondary
- To determine whether breast-related symptoms and cosmesis from accelerated WBI that is
hypofractionated (in only 3 weeks) with a concomitant boost is non-inferior to standard
WBI with sequential boost.
- To determine whether the risk of late cardiac toxicity in patients with left-sided
breast cancer treated with hypofractionation will be non-inferior to conventional
fractionated radiation therapy (RT) based upon analysis of radiation dosimetry from
CT-based treatment planning and NTCP calculations.
- To determine whether CT-based conformal methods intensity-modulated radiation therapy
(IMRT) and three-dimensional conformal radiotherapy (3D-CRT) for WBI are feasible in a
multi-institutional setting following lumpectomy in early-stage breast cancer patients
and whether dose-volume analyses can be established to assess treatment adequacy and
likelihood of toxicity.
- To determine that cosmetic results and breast-related symptoms 3 years after
hypofractionated breast radiation with concomitant boost will not be inferior to that
obtained 3 years after WBI with sequential boost.
- To determine whether future correlative studies can identify individual gene
expressions and biological host factors associated with toxicity and/or local
recurrence from standard and hypofractionated WBI.
- If shown to be non-inferior, to then determine if accelerated course of
hypofractionated WBI including a concomitant boost to the tumor bed in 15 fractions
following lumpectomy will prove to be superior in local control to a regimen of
standard WBI with a sequential boost following lumpectomy for early-stage breast cancer
patients.
- To determine whether treatment costs for hypofractionated WBI with concomitant boost
are not higher than WBI with sequential boost.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 vs. ≥
50 years), prior chemotherapy (yes vs. no), estrogen-receptor status (+ vs. -), and
histology grade (1-2 vs. 3). Patients are randomized to 1 of 2 treatment arms. Treatment
begins within 9 weeks of last surgery or chemotherapy delivery.
- Arm I: Patients undergo standard whole-breast radiotherapy (WBI) comprising
intensity-modulated radiation therapy (IMRT) or three-dimensional conformal
radiotherapy (3D-CRT) 5 days a week for 3-5 weeks followed by a sequential radiotherapy
boost to the lumpectomy area 5 days a week for 1-1½ weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo accelerated hypofractionated WBI comprising IMRT or 3D-CRT
with a concurrent boost to the lumpectomy area 5 days a week for 3 weeks. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Patients' tissue samples may be collected for future research studies.
After completion of study therapy, patients are followed at 1 month, at 6 months, and then
yearly.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local control
From randomization to the date of first local failure or last follow-up. Analysis occurs after 245 local failures have been reported.
No
Frank Vicini, MD, FACR
Principal Investigator
William Beaumont Hospital - Royal Oak Campus
United States: Federal Government
RTOG 1005
NCT01349322
May 2011
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Henry Ford Hospital | Detroit, Michigan 48202 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Community Medical Center | Toms River, New Jersey 08755 |
Akron General Medical Center | Akron, Ohio 44302 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
York Hospital | York, Pennsylvania 17315 |
Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Staten Island University Hospital | Staten Island, New York 10305 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Parma Community General Hospital | Parma, Ohio 44129 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Logan Regional Hospital | Logan, Utah 84321 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Providence Medford Medical Center | Medford, Oregon 97504 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Washington Hospital Center | Washington, District of Columbia 20010 |
City of Hope | Duarte, California 91010 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Cancer Care Northwest | Spokane, Washington 99202 |
Duke University Medical Center | Durham, North Carolina 27710 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
University of Florida | Gainesville, Florida 32610-0277 |
University of Rochester | Rochester, New York 14642 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Emory University | Atlanta, Georgia 30322 |
Wayne State University | Detroit, Michigan 48202 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Saint Mary's Regional Medical Center | Reno, Nevada 89503 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
University of New Mexico | Albuquerque, New Mexico 87131 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Appleton Medical Center | Appleton, Wisconsin 54911 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Jersey Shore Medical Center | Neptune, New Jersey 07754 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
West Texas Cancer Center | Odessa, Texas 79761 |
Virginia Commonwealth University | Richmond, Virginia |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Santa Clara Valley Medical Center | San Jose, California 95128 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
Hudson Valley Oncology Associates | Poughkeepsie, New York 12601 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Southern California | Los Angeles, California 90033 |
Inova Alexandria Hospital | Alexandria, Virginia 22304 |
Rohnert Park Cancer Center | Rohnert Park, California 94928 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Northside Hospital | Atlanta, Georgia 30342 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Edna Williams Cancer Center at the Baptist Cancer Institute | Jacksonville, Florida 32207 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Finley Hospital | Dubuque, Iowa 52001 |
Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
North Shore Medical Center Cancer Center | Peabody, Massachusetts 01960 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Northern Michigan Regional Hospital | Petoskey, Michigan 49770 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Billings Clinic | Billings, Montana 59107-7000 |
Ocean Medical Center | Brick, New Jersey 08724 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Sparta Cancer Treatment Center | Sparta, New Jersey 07871 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Memorial Medical Center - Las Cruces | Las Cruces, New Mexico 88011 |
Columbia University Medical Center | New York, New York 10032 |
Highland Hospital | Rochester, New York 14620 |
Summa Barberton Hospital | Barberton, Ohio 44203 |
Cleveland Clinic Cancer Center Independence | Independence, Ohio 44131 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Saint Joseph Medical Center | Reading, Pennsylvania 19605 |
Greenville CCOP | Greenville, South Carolina 29615 |
Saint Francis Hospital | Federal Way, Washington 98003 |
Edwards Comprehensive Cancer Center | Huntington, West Virginia 25701 |
West Virginia University | Morgantown, West Virginia 26506 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Central Wisconsin Cancer Program | Fond Du Lac, Wisconsin 54935 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Aspirus Regional Cancer Center | Wausau, Wisconsin 54401 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Radiological Associates of Sacramento | Sacramento, California 95816 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
The Nebraska Medical Center | Omaha, Nebraska 68198 |
Henry Ford Macomb Hospital | Clinton Township, Michigan 48038 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Baylor Medical Center at Irving | Irving, Texas 75061 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Moores University of California San Diego Cancer Center | LA Jolla, California 92093 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Saint Agnes Hospital | Baltimore, Maryland 21229 |
Renown Regional Medical Center | Reno, Nevada 89502 |
The Regional Cancer Center | Erie, Pennsylvania 16505 |
Saint Mary Medical and Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Radiation Oncology | Greer, South Carolina 29650 |
Texas Oncology - Round Rock Cancer Center | Round Rock, Texas 78681 |
Intermountain Medical Center | Murray, Utah 84157 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Wheaton Franciscan Cancer Care - All Saints | Racine, Wisconsin 53405 |
Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin 53081 |
Aurora Medical Center in Summit | Summit, Wisconsin 53066 |
Texas Cancer Center-Sherman | Sherman, Texas 75090 |
Kansas City Cancer Centers-Southwest | Overland Park, Kansas 66210 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
Grady Health System | Atlanta, Georgia 30303 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Kaiser Permanente Oakland-Broadway | Oakland, California 94611 |
Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cardova, California 95670 |
The Permanente Medical Group-Roseville Radiation Oncology | Roseville, California 95678 |
Kaiser Permanente Radiation Oncology Cancer Treatment Center | Santa Clara, California 95051 |
Kaiser Permanente Cancer Treatment Center | South San Francisco, California 94080 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Saint John's Health System Cancer Center | Anderson, Indiana 46016 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Owensboro Mercy Medical Center | Owensboro, Kentucky 42303 |
Kansas City Cancer Center - South | Kansas City, Missouri 64131 |
Kansas City Cancer Center-Lee's Summit | Lee's Summit, Missouri 64064 |
The Christ Hospital | Cincinnati, Ohio 45219 |
UHHS-Chagrin Highlands Medical Center | Orange Village, Ohio 44122 |
UHHS-Westlake Medical Center | Westlake, Ohio 44145 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
New York Oncology Hematology PC - Albany | Albany, New York 12206 |
Lexington Medical Center | West Columbia, South Carolina 29169 |
Community Regional Cancer Care-East Radiation Oncology | Indianapolis, Indiana 46219 |
Community Regional Cancer Care-North | Indianapolis, Indiana 46256 |
New Hanover Radiation Oncology Center | Wilmington, North Carolina 28401 |
Robinson Radiation Oncology | Ravenna, Ohio 44266 |
Los Angeles County-USC Medical Center | Los Angeles, California 90033 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Northside Hospital-Forsyth | Cumming, Georgia 30041 |
Beloit Memorial Hospital | Beloit, Wisconsin 53511 |
Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Texas Oncology - Lewisville | Lewisville, Texas 75067 |
The Kirklin Clinic at Acton Road | Birmingham, Alabama 35243 |
Enloe Medical Center | Chico, California 95926 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Hematology Oncology Associates of Central New York PC | East Syracuse, New York 13057 |
Texas Oncology-Wichita Falls Texoma Cancer Center | Wichita Fall, Texas 76310 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Barnes West County Hospital | Saint Louis, Missouri 63141 |
Siteman Cancer Center - Saint Peters | Saint Peters, Missouri 63376 |
Door County Cancer Center | Sturgeon Bay, Wisconsin 54235-1495 |
Indiana University Health Goshen Center For Cancer Care | Goshen, Indiana 46526 |
Texas Oncology-Arlington South | Arlington, Texas 76014 |
South Atlantic Radiation Oncology | Supply, North Carolina 28462 |
City of Hope- South Pasadena Cancer Center | South Pasadena, California 91030 |
Texas Oncology-Denton South | Denton, Texas 76210 |
North Shore-LIJ Health System CCOP | Manhasset, New York 11030 |
Riverview Medical Center/Booker Cancer Center | Red Bank, New Jersey 07701 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Cancer Specialists of North Florida-Baptist South | Jascksonville, Florida 32258 |
Cancer Specialists of North Florida-Putnam | Palatka, Florida 32177 |
Cancer Specialists of North Florida-Saint Augustine | Saint Augustine, Florida 32086 |
IU Health Methodist Hospital | Indianapolis, Indiana 46202 |
Memorial Sloan-Kettering Cancer Center at Suffolk | Commack, New York 11725 |
Mayo Clinic Health System-Franciscan Healthcare | La Crosse, Wisconsin 54601 |
Auburn Radiation Oncology Center | Auburn, California 95603 |
Marshall Radiation Oncology Center | Cameron Park, California 95682 |
Mercy San Juan Medical Center | Carmichael, California 95608 |
Roseville Radiation Oncology Center | Roseville, California 95661 |
Norris Cotton Cancer Center-North | Saint Johnsbury, Vermont 05819 |
IU Health Ball Memorial Hospital | Muncie, Indiana 47303 |
Rockingham Memorial Hospital Hahn Cancer Center | Harrisonburg, Virginia 22801 |
Holy Redeemer Hospital and Medical Center | Meadowbrook, Pennsylvania 19046 |
Cleveland Clinic Cancer Center-Strongsville | Strongsville, Ohio 44136 |
Capital Health Medical Center-Hopewell | Pennington, New Jersey 08534 |
Cape Radiation Oncology | Cape Girardeau, Missouri 63703 |
LC Ferguson Cancer Center | Freeport, Illinois 61032 |
Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge, New Jersey 07920 |
Memorial Sloan-Kettering Cancer Center Rockville Centre | Rockville Centre, New York 11570 |
Memorial Sloan-Kettering Cancer Center at Phelps | Sleepy Hollow, New York 10591 |
Arizona Oncology Associates-West Orange Grove | Tucson, Arizona 85704 |
University Radiation Oncology | Rochester, New York 14626 |
Texas Oncology PA - Bedford | Bedford, Texas 76022 |
The Klabzuba Cancer Center | Fort Worth, Texas 76104 |
Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Central Maryland Radiation Oncology in Howard County | Columbia, Maryland 21044 |
Saint John's Hospital | Springfield, Illinois 62702 |
Cancer Care Centers of South Texas- Northeast | San Antonio, Texas 78217 |
Radiation Oncology Centers of Las Vegas - Tonopah | Las Vegas, Nevada 89106 |
Saint Peters Hospital-Albany | Albany, New York 12208 |
21st Century Oncology-Scottsdale | Scottsdale, Arizona 85251 |
John Fitzgerald Kennedy Medical Center | Atlantis, Florida 33462 |
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach, Florida 33442 |
IU Health West | Avon, Indiana 46123 |
Tate Cancer Center | Glen Burnie, Maryland 21061 |
21st Century Oncology-Farmington Hills | Farmington Hills, Michigan 48334 |
Cayuga Medical Center | Ithaca, New York 14850 |
The Coleman Radiation Center-Carteret General Hospital | Morehead City, North Carolina 28557 |
CarolinaEast Health System-Medical Center | New Bern, North Carolina 28560 |
The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island, South Carolina 29926 |
Memorial Hermann Memorial City Medical Center | Houston, Texas 77024 |
Augusta Health Cancer Center | Fishersville, Virginia 22939 |