Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01349322
First received: May 5, 2011
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.


Condition Intervention Phase
Breast Cancer
Radiation: Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy
Radiation: Higher per daily radiation therapy
Radiation: Concurrent boost radiotherapy
Radiation: Standard per daily radiation therapy
Radiation: Sequential boost radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Local control [ Time Frame: From randomization to the date of first local failure or last follow-up. Analysis occurs after 245 local failures have been reported. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death due to any cause or last follow-up. ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: From randomization to date of local-regional disease recurrence, distant metastases, second primary, death due to any cause or last follow-up. ] [ Designated as safety issue: No ]
  • Distant disease-free survival [ Time Frame: From randomization to date of distant metastases, second primary, death due to any cause or last follow-up. ] [ Designated as safety issue: No ]
  • Changes in breast-related symptoms and side effects and cosmesis [ Time Frame: From randomization to three years. ] [ Designated as safety issue: No ]
  • Correlation between dose-volume data and both adverse events and efficacy [ Time Frame: From randomization to end of follow-up. ] [ Designated as safety issue: No ]
  • Treatment cost of accelerated course of hypofractionated WBI versus standard WBI with a sequential boost [ Time Frame: From randomization to end of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2312
Study Start Date: May 2011
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 in the absence of disease progression or unacceptable toxicity.
Radiation: Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy
Patients undergo whole breast radiotherapy by 3D-CRT or IMRT
Radiation: Standard per daily radiation therapy
Patients undergo standard per daily radiation therapy
Radiation: Sequential boost radiotherapy
Patients undergo sequential boost radiotherapy
Experimental: 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 in the absence of disease progression or unacceptable toxicity.
Radiation: Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy
Patients undergo whole breast radiotherapy by 3D-CRT or IMRT
Radiation: Higher per daily radiation therapy
Patients undergo higher per daily radiation therapy
Radiation: Concurrent boost radiotherapy
Patients undergo concurrent boost radiotherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole-breast irradiation (WBI) with boost without regional nodal irradiation planned
  • Must meet one of the following three criteria:

    • pStage I or II breast cancer AND at least one of the following:

      • Age < 50 years or
      • Positive axillary nodes or
      • Lymphovascular space invasion (LVI) or
      • At least 2 close resection margins (> 0 mm to ≤ 2 mm) or
      • One close resection margin and extensive in-situ component (EIC) or
      • Focally positive resection margins or
      • Non-hormone-sensitive breast cancer (estrogen and progesterone receptor negative (ER- and PR-) or
      • Grade III histology or
      • Oncotype recurrence score > 25 or
    • pStage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years or
  • If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
  • Breast-conserving surgery with margins defined as follows:

    • Negative margins defined as no tumor at the resected specimen edge
    • Close resection margins > 0 mm to ≤ 2 mm as follows:

      • One close resection margin and EIC
      • Two or more close resection margins
    • A focally positive resection margin
  • Allowable options for mandatory axillary staging include:

    • Sentinel node biopsy alone (if sentinel node is negative, pN0, pN0[IHC-,+])
    • Sentinel node biopsy alone, OR followed by axillary node dissection, for clinically node-negative patients as described below:

      • Microscopic sentinel node (SN) positive (pN1mic)
      • One or two SNs positive (pN1) without extracapsular extension
      • Negative SN biopsy after neoadjuvant chemotherapy
    • Axillary node dissection is required following SN biopsy with a minimum total of 6 axillary nodes if any of the following exist:

      • For > 2 positive SN
      • Any positive SN biopsy after neoadjuvant chemotherapy
      • For clinically (by either imaging or examination) T3 disease
      • For extracapsular extension
    • Axillary dissection alone (with a minimum of 6 axillary nodes)
  • CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatment planning.

    • Must be able to delineate on CT scan the extent of the target lumpectomy cavity for boost (placement of surgical clips to assist in treatment planning of the boost is strongly recommended)
  • No clinical evidence for distant metastases, based upon the following minimum diagnostic workup:

    • History/physical examination, including breast exam (inspection and palpation of the breasts) and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
    • A mammogram of both right and left breast within only 1 time point of 90 days of the diagnostic biopsy establishing the diagnosis
  • No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
  • No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast cancer
  • Must not have two or more breast cancers that are not resectable through a single lumpectomy incision
  • Must not be DCIS and ≥ 50 years old
  • Must not be DCIS only (without an invasive component), nuclear grade 1 or 2 and < 50 years old
  • No suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
  • No non-epithelial breast malignancies such as sarcoma or lymphoma
  • No Paget disease of the nipple
  • No male breast cancer
  • Breast implants allowed

PATIENT CHARACTERISTICS:

  • ANC ≥ 1,800/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • Negative urine or serum pregnancy test within 14 days of study entry
  • Women of childbearing potential must not be pregnant or nursing and willing to use medically acceptable form of contraception during radiotherapy
  • No prior invasive non-breast malignancy (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
  • No severely active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired Immune-Deficiency Syndrome (AIDS) based upon current CDC definition

      • HIV testing is not required for entry into this protocol
  • No active systemic lupus, erythematosus, or any history of scleroderma or dermatomyositis with active rash
  • Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Study entry must be within 50 days of last breast/axillary surgery and/or last chemotherapy
  • No treatment plan that includes regional-node radiotherapy
  • No prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
  • No intention to administer concurrent chemotherapy for current breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349322

  Hide Study Locations
Locations
United States, Alabama
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
21st Century Oncology-Scottsdale
Scottsdale, Arizona, United States, 85251
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States, 85704
United States, Arkansas
Mercy Cancer Center-Hot Springs
Hot Springs, Arkansas, United States, 71913
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Medical Center
Chico, California, United States, 95926
City of Hope
Duarte, California, United States, 91010
Epic Care-Dublin
Dublin, California, United States, 94568
21st Century Oncology - El Segundo
El Segundo, California, United States, 90245
UC San Diego Moores Cancer Center
LA Jolla, California, United States, 92093
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California at Los Angeles (UCLA )
Los Angeles, California, United States, 90095
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cardova, California, United States, 95670
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Sutter General Hospital
Sacramento, California, United States, 95816
South Sacramento Cancer Center
Sacramento, California, United States, 95823
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Kaiser Permanente Radiation Oncology Cancer Treatment Center
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
The Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
McKee Medical Center
Loveland, Colorado, United States, 80539
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, United States, 33462
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, United States, 32117
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
21st Century Oncology - Fort Walton Beach
Fort Walton Beach, Florida, United States, 32547
University of Florida
Gainesville, Florida, United States, 32610
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Cancer Specialists of North Florida-Southside
Jacksonville, Florida, United States, 32207
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Cancer Specialists of North Florida-Beaches
Jacksonville Beach, Florida, United States, 32250
Cancer Specialists of North Florida-Baptist South
Jascksonville, Florida, United States, 32258
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Cancer Specialists of North Florida-Orange Park
Orange Park, Florida, United States, 32073
Florida Hospital
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Cancer Specialists of North Florida-Putnam
Palatka, Florida, United States, 32177
Cancer Specialists of North Florida-Saint Augustine
Saint Augustine, Florida, United States, 32086
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
The Villages Regional Hospital
The Villages, Florida, United States, 32159
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Grady Health System
Atlanta, Georgia, United States, 30303
Northside Hospital
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Northside Hospital-Forsyth
Cumming, Georgia, United States, 30041
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
FHN Leonard C. Ferguson Cancer Center
Freeport, Illinois, United States, 61032
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
Peoria, Illinois, United States, 61615-7827
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61107
Saint John's Hospital
Springfield, Illinois, United States, 62702
Carle Cancer Center
Urbana, Illinois, United States, 61801
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States, 46016
IU Health West Hospital
Avon, Indiana, United States, 46123
IU Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Community Regional Cancer Care-East Radiation Oncology
Indianapolis, Indiana, United States, 46219
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
IU Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Iowa
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States, 21044
Tate Cancer Center
Glen Burnie, Maryland, United States, 21061
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
North Shore Medical Center Cancer Center
Peabody, Massachusetts, United States, 01960
United States, Michigan
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
21st Century Oncology-Clarkston
Clarkston, Michigan, United States, 48346
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States, 48038
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Botsford General Hospital
Farmington, Michigan, United States, 48334
21st Century Oncology-Farmington Hills
Farmington Hills, Michigan, United States, 48334
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
McLaren-Flint
Flint, Michigan, United States, 48532
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
KCC Radiation Oncology at Monroe Cancer Center
Monroe, Michigan, United States, 48162
Northern Michigan Regional Hospital
Petoskey, Michigan, United States, 49770
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Providence Hospital
Southfield, Michigan, United States, 48075
21st Century Oncology-Troy
Troy, Michigan, United States, 48098
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Mississippi
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cape Radiation Oncology
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Liberty Hospital
Liberty, Missouri, United States, 64068
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States, 63376
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Ocean Medical Center
Brick, New Jersey, United States, 08724
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Jersey Shore Medical Center
Neptune, New Jersey, United States, 07753
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, United States, 07701
Sparta Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Overlook Hospital
Summit, New Jersey, United States, 07902
Community Medical Center
Toms River, New Jersey, United States, 08755
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
Saint Peters Hospital-Albany
Albany, New York, United States, 12208
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sands Cancer Center
Canandiaqua, New York, United States, 14424
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States, 11725
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
Cayuga Medical Center
Ithaca, New York, United States, 14850
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Columbia University Medical Center
New York, New York, United States, 10032
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States, 12601
Highland Hospital
Rochester, New York, United States, 14620
University of Rochester
Rochester, New York, United States, 14642
Rochester General Hospital
Rochester, New York, United States, 14621
University Radiation Oncology
Rochester, New York, United States, 14626
Memorial Sloan-Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Sleepy Hallow
Sleepy Hollow, New York, United States, 10591
Staten Island University Hospital
Staten Island, New York, United States, 10305
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Dickstein Cancer Treatment Center
White Plains, New York, United States, 10601
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27858
The Coleman Radiation Center-Carteret General Hospital
Morehead City, North Carolina, United States, 28557
CarolinaEast Health System-Medical Center
New Bern, North Carolina, United States, 28560
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
South Atlantic Radiation Oncology
Supply, North Carolina, United States, 28462
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Geaugra Hospital
Chardon, Ohio, United States, 44024
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center-Strongsville
Strongsville, Ohio, United States, 44136
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Medford Medical Center
Medford, Oregon, United States, 97504
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC - HVHS Cancer Center at Heritage Valley Beaver
Beaver, Pennsylvania, United States, 15009
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States, 18925
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Holy Redeemer Hospital and Medical Center
Meadowbrook, Pennsylvania, United States, 19046
Riddle Hospital
Media, Pennsylvania, United States, 19063
Intercommunity Cancer Center
Monroeville, Pennsylvania, United States, 15146
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Township, Pennsylvania, United States, 15108
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, United States, 15065
Jameson Health System North Campus
New Castle, Pennsylvania, United States, 16105
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Saint Joseph Medical Center
Reading, Pennsylvania, United States, 19605
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013
Washington Hospital
Washington, Pennsylvania, United States, 15301
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute/Greenville CCOP
Greenville, South Carolina, United States, 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, United States, 29926
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Texas Oncology-Arlington South
Arlington, Texas, United States, 76014
Texas Oncology - South Austin Cancer Center
Austin, Texas, United States, 78745
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology PA - Bedford
Bedford, Texas, United States, 76022
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Oncology-Denton South
Denton, Texas, United States, 76210
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
The Klabzuba Cancer Center
Fort Worth, Texas, United States, 76104
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
Baylor Medical Center at Irving
Irving, Texas, United States, 75061
Texas Oncology - Lewisville
Lewisville, Texas, United States, 75067
West Texas Cancer Center
Odessa, Texas, United States, 79761
Texas Oncology-Plano West
Plano, Texas, United States, 75093
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, United States, 78681
Texas Oncology-Seton Williamson
Round Rock, Texas, United States, 78665
Cancer Care Centers of South Texas- Northeast
San Antonio, Texas, United States, 78217
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Utah
Logan Regional Hospital
Logan, Utah, United States, 84321
Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Augusta Health Cancer Center
Fishersville, Virginia, United States, 22939
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States, 23666
Rockingham Memorial Hospital Hahn Cancer Center
Harrisonburg, Virginia, United States, 22801
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Harrison Medical Center
Bremerton, Washington, United States, 98310
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Tri-Cities Cancer Center
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Olympic Medical Cancer Care Center
Sequim, Washington, United States, 98384
Cancer Care Northwest-North Spokane
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Appleton Medical Center
Appleton, Wisconsin, United States, 54911
Beloit Memorial Hospital
Beloit, Wisconsin, United States, 53511
Mayo Clinic Health System Eau Claire Hospital - Luther Campus
Eau Claire, Wisconsin, United States, 54703
Agnesian Cancer Center
Fond Du Lac, Wisconsin, United States, 54935
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States, 53211
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, United States, 53405
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States, 54235-1495
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, United States, 54241
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
Ottawa Health Research Institute-General Division
Ottawa, Ontario, Canada, K1H 1C4
Irving Greenberg Family Cancer Centre
Ottawa, Ontario, Canada, K2H 8P4
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada, H7M 3L9
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUQ - Pavilion Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Israel
Rabin Medical Center
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Japan
Shizuoka Cancer Center
Shizuoka City, Suntou, Japan, 411-8777
Korea, Republic of
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Yonsei University Health System-Severance Hospital
Seoul, Korea, Republic of, 120-752
Singapore
National Cancer Centre
Singapore, Singapore, 169610
National University Hospital
Singapore, Singapore, 119074
Switzerland
Kantonsspital Aarau AG-Canton Hospital
Aarau, Switzerland, 5001
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Frank A. Vicini, MD, FACR St. Joseph Mercy Oakland
Study Chair: Gary M. Freedman, MD University of Pennsylvania
Study Chair: Julia R. White, MD Ohio State University
Study Chair: Douglas W. Arthur, MD Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01349322     History of Changes
Other Study ID Numbers: RTOG 1005, NCI-2011-02669, CDR0000700069
Study First Received: May 5, 2011
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014