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

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01349322
Collaborator
National Cancer Institute (NCI) (NIH), NRG Oncology (Other)
2,354
415
2
5.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2354 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Actual Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jan 25, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Local control [From randomization to the date of first local failure or last follow-up. Analysis occurs after 245 local failures have been reported.]

Secondary Outcome Measures

  1. Overall survival [From randomization to date of death due to any cause or last follow-up.]

  2. Disease-free survival [From randomization to date of local-regional disease recurrence, distant metastases, second primary, death due to any cause or last follow-up.]

  3. Distant disease-free survival [From randomization to date of distant metastases, second primary, death due to any cause or last follow-up.]

  4. Changes in breast-related symptoms and side effects and cosmesis [From randomization to three years.]

  5. Correlation between dose-volume data and both adverse events and efficacy [From randomization to end of follow-up.]

  6. Treatment cost of accelerated course of hypofractionated WBI versus standard WBI with a sequential boost [From randomization to end of treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
2 The Kirklin Clinic at Acton Road Birmingham Alabama United States 35243
3 21st Century Oncology-Scottsdale Scottsdale Arizona United States 85251
4 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
5 Arizona Oncology Associates-West Orange Grove Tucson Arizona United States 85704
6 Banner University Medical Center - Tucson Tucson Arizona United States 85719
7 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
8 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
9 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
10 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
11 Mercy San Juan Medical Center Carmichael California United States 95608
12 Enloe Medical Center Chico California United States 95926
13 City of Hope Comprehensive Cancer Center Duarte California United States 91010
14 Epic Care-Dublin Dublin California United States 94568
15 21st Century Oncology - El Segundo El Segundo California United States 90245
16 UC San Diego Moores Cancer Center La Jolla California United States 92093
17 Los Angeles County-USC Medical Center Los Angeles California United States 90033
18 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
19 Cedars Sinai Medical Center Los Angeles California United States 90048
20 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
21 Kaiser Permanente Oakland-Broadway Oakland California United States 94611
22 Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California United States 95670
23 Rohnert Park Cancer Center Rohnert Park California United States 94928
24 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
25 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
26 Sutter Medical Center Sacramento Sacramento California United States 95816
27 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
28 South Sacramento Cancer Center Sacramento California United States 95823
29 Santa Clara Valley Medical Center San Jose California United States 95128
30 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
31 City of Hope South Pasadena South Pasadena California United States 91030
32 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
33 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
34 University of Colorado Hospital Aurora Colorado United States 80045
35 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
36 Porter Adventist Hospital Denver Colorado United States 80210
37 Shaw Cancer Center Edwards Colorado United States 81632
38 McKee Medical Center Loveland Colorado United States 80539
39 Hartford Hospital Hartford Connecticut United States 06102
40 MedStar Washington Hospital Center Washington District of Columbia United States 20010
41 John Fitzgerald Kennedy Medical Center Atlantis Florida United States 33462
42 Florida Hospital Memorial Medical Center Daytona Beach Florida United States 32117
43 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
44 21st Century Oncology - Fort Walton Beach Fort Walton Beach Florida United States 32547
45 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
46 Integrated Community Oncology Network-Florida Cancer Center Beaches Jacksonville Beach Florida United States 32250
47 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
48 Integrated Community Oncology Network-Southside Cancer Center Jacksonville Florida United States 32207
49 University of Florida Health Science Center - Jacksonville Jacksonville Florida United States 32209
50 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
51 Baptist Medical Center South Jacksonville Florida United States 32258
52 Jackson Memorial Hospital-Holtz Children's Hospital Miami Florida United States 33136
53 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
54 21st Century Oncology-Orange Park Orange Park Florida United States 32073
55 AdventHealth Orlando Orlando Florida United States 32803
56 Orlando Health Cancer Institute Orlando Florida United States 32806
57 Cancer Center of Putnam Palatka Florida United States 32177
58 Integrated Community Oncology Network-Flager Cancer Center Saint Augustine Florida United States 32086
59 Moffitt Cancer Center Tampa Florida United States 33612
60 The Villages Regional Hospital The Villages Florida United States 32159
61 Grady Health System Atlanta Georgia United States 30303
62 Emory University Hospital Midtown Atlanta Georgia United States 30308
63 Piedmont Hospital Atlanta Georgia United States 30309
64 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
65 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
66 Northside Hospital Atlanta Georgia United States 30342
67 Northside Hospital-Forsyth Cumming Georgia United States 30041
68 Memorial Health University Medical Center Savannah Georgia United States 31404
69 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
70 Queen's Medical Center Honolulu Hawaii United States 96813
71 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
72 Rush - Copley Medical Center Aurora Illinois United States 60504
73 Northwestern University Chicago Illinois United States 60611
74 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
75 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
76 Decatur Memorial Hospital Decatur Illinois United States 62526
77 Freeport Memorial Hospital/Leonard C Ferguson Cancer Center Freeport Illinois United States 61032
78 Loyola University Medical Center Maywood Illinois United States 60153
79 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
80 Carle Cancer Institute Normal Normal Illinois United States 61761
81 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
82 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
83 OSF Saint Francis Medical Center Peoria Illinois United States 61637
84 Swedish American Hospital Rockford Illinois United States 61104
85 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61114
86 Saint John's Hospital Springfield Illinois United States 62702
87 Carle Cancer Center Urbana Illinois United States 61801
88 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
89 Saint Vincent Anderson Regional Hospital/Cancer Center Anderson Indiana United States 46016
90 IU Health West Hospital Avon Indiana United States 46123
91 Goshen Center for Cancer Care Goshen Indiana United States 46526
92 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
93 IU Health Methodist Hospital Indianapolis Indiana United States 46202
94 Community Cancer Center East Indianapolis Indiana United States 46219
95 Community Cancer Center North Indianapolis Indiana United States 46256
96 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana United States 46545
97 IU Health Ball Memorial Hospital Muncie Indiana United States 47303
98 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
99 Iowa Methodist Medical Center Des Moines Iowa United States 50309
100 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
101 Finley Hospital Dubuque Iowa United States 52001
102 University of Kansas Cancer Center Kansas City Kansas United States 66160
103 Lawrence Memorial Hospital Lawrence Kansas United States 66044
104 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
105 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
106 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
107 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
108 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
109 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
110 Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky United States 42303
111 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
112 Anne Arundel Medical Center Annapolis Maryland United States 21401
113 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
114 Greater Baltimore Medical Center Baltimore Maryland United States 21204
115 Saint Agnes Hospital Baltimore Maryland United States 21229
116 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
117 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
118 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland United States 21061
119 TidalHealth Peninsula Regional Salisbury Maryland United States 21801
120 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
121 Boston Medical Center Boston Massachusetts United States 02118
122 Mass General/North Shore Cancer Center Danvers Massachusetts United States 01923
123 Lowell General Hospital Lowell Massachusetts United States 01854
124 Newton-Wellesley Hospital Newton Massachusetts United States 02462
125 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
126 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
127 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
128 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
129 Henry Ford Hospital Detroit Michigan United States 48202
130 Ascension Saint John Hospital Detroit Michigan United States 48236
131 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
132 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
133 Beaumont Hospital - Farmington Hills Farmington Hills Michigan United States 48336
134 McLaren Cancer Institute-Flint Flint Michigan United States 48532
135 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
136 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
137 West Michigan Cancer Center Kalamazoo Michigan United States 49007
138 KCC Radiation Oncology at Monroe Cancer Center Monroe Michigan United States 48162
139 McLaren Cancer Institute-Northern Michigan Petoskey Michigan United States 49770
140 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
141 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
142 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
143 William Beaumont Hospital - Troy Troy Michigan United States 48085
144 GenesisCare USA - Troy Troy Michigan United States 48098
145 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
146 Mayo Clinic Health System in Albert Lea Albert Lea Minnesota United States 56007
147 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
148 Miller-Dwan Hospital Duluth Minnesota United States 55805
149 Mayo Clinic Health Systems-Mankato Mankato Minnesota United States 56001
150 Mayo Clinic in Rochester Rochester Minnesota United States 55905
151 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
152 Singing River Hospital Pascagoula Mississippi United States 39581
153 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
154 Saint Luke's Hospital Chesterfield Missouri United States 63017
155 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
156 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
157 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
158 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
159 Liberty Radiation Oncology Center Liberty Missouri United States 64068
160 Washington University School of Medicine Saint Louis Missouri United States 63110
161 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
162 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
163 Billings Clinic Cancer Center Billings Montana United States 59101
164 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
165 Kalispell Regional Medical Center Kalispell Montana United States 59901
166 Nebraska Methodist Hospital Omaha Nebraska United States 68114
167 University of Nebraska Medical Center Omaha Nebraska United States 68198
168 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
169 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
170 Renown Regional Medical Center Reno Nevada United States 89502
171 Saint Mary's Regional Medical Center Reno Nevada United States 89503
172 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
173 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
174 Ocean Medical Center Brick New Jersey United States 08724
175 Monmouth Medical Center Long Branch New Jersey United States 07740
176 Morristown Medical Center Morristown New Jersey United States 07960
177 Virtua Memorial Mount Holly New Jersey United States 08060
178 Jersey Shore Medical Center Neptune New Jersey United States 07753
179 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
180 Capital Health Medical Center-Hopewell Pennington New Jersey United States 08534
181 Riverview Medical Center/Booker Cancer Center Red Bank New Jersey United States 07701
182 Sparta Cancer Treatment Center Sparta New Jersey United States 07871
183 Overlook Hospital Summit New Jersey United States 07902
184 Community Medical Center Toms River New Jersey United States 08755
185 Virtua Voorhees Voorhees New Jersey United States 08043
186 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
187 Memorial Medical Center - Las Cruces Las Cruces New Mexico United States 88011
188 New York Oncology Hematology PC - Albany Albany New York United States 12206
189 Saint Peter's Health Partners Albany New York United States 12208
190 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
191 Roswell Park Cancer Institute Buffalo New York United States 14263
192 Sands Cancer Center Canandaigua New York United States 14424
193 Memorial Sloan Kettering Commack Commack New York United States 11725
194 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
195 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
196 Cayuga Medical Center Ithaca New York United States 14850
197 Northwell Health NCORP Lake Success New York United States 11042
198 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
199 Long Island Jewish Medical Center New Hyde Park New York United States 11040
200 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
201 Memorial Sloan Kettering Cancer Center New York New York United States 10065
202 Hudson Valley Oncology Associates Poughkeepsie New York United States 12601
203 Wilmot Cancer Institute Radiation Oncology at Greece Rochester New York United States 14606
204 Highland Hospital Rochester New York United States 14620
205 Rochester General Hospital Rochester New York United States 14621
206 University of Rochester Rochester New York United States 14642
207 Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York United States 10591
208 Staten Island University Hospital Staten Island New York United States 10305
209 Stony Brook University Medical Center Stony Brook New York United States 11794
210 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
211 Dickstein Cancer Treatment Center White Plains New York United States 10601
212 Duke University Medical Center Durham North Carolina United States 27710
213 East Carolina University Greenville North Carolina United States 27834
214 The Coleman Radiation Center-Carteret General Hospital Morehead City North Carolina United States 28557
215 CarolinaEast Medical Center New Bern North Carolina United States 28561
216 FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina United States 28374
217 Iredell Memorial Hospital Statesville North Carolina United States 28677
218 NHRMC Radiation Oncology - Supply Supply North Carolina United States 28462
219 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
220 NHRMC Radiation Oncology - 16th Street Wilmington North Carolina United States 28401
221 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
222 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
223 Altru Cancer Center Grand Forks North Dakota United States 58201
224 Summa Health System - Akron Campus Akron Ohio United States 44304
225 Cleveland Clinic Akron General Akron Ohio United States 44307
226 Summa Health System - Barberton Campus Barberton Ohio United States 44203
227 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
228 Geauga Hospital Chardon Ohio United States 44024
229 Adena Regional Medical Center Chillicothe Ohio United States 45601
230 The Christ Hospital Cincinnati Ohio United States 45219
231 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
232 Case Western Reserve University Cleveland Ohio United States 44106
233 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
234 Cleveland Clinic Foundation Cleveland Ohio United States 44195
235 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
236 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
237 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
238 Summa Health Medina Medical Center Medina Ohio United States 44256
239 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
240 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
241 University Hospitals Parma Medical Center Parma Ohio United States 44129
242 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
243 North Coast Cancer Care Sandusky Ohio United States 44870
244 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
245 UHHS-Westlake Medical Center Westlake Ohio United States 44145
246 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
247 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
248 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
249 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
250 Willamette Valley Cancer Center Eugene Oregon United States 97401
251 Three Rivers Community Hospital Grants Pass Oregon United States 97527
252 Providence Medford Medical Center Medford Oregon United States 97504
253 Rogue Valley Medical Center Medford Oregon United States 97504
254 Providence Portland Medical Center Portland Oregon United States 97213
255 Jefferson Abington Hospital Abington Pennsylvania United States 19001
256 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
257 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
258 Geisinger Medical Center Danville Pennsylvania United States 17822
259 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
260 Northeast Radiation Oncology Center Dunmore Pennsylvania United States 18512
261 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
262 UPMC Hillman Cancer Center Erie Erie Pennsylvania United States 16505
263 Fox Chase Cancer Center Buckingham Furlong Pennsylvania United States 18925
264 Adams Cancer Center Gettysburg Pennsylvania United States 17325
265 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
266 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
267 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
268 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
269 Lancaster General Hospital Lancaster Pennsylvania United States 17602
270 Saint Mary Medical and Regional Cancer Center Langhorne Pennsylvania United States 19047
271 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
272 Holy Redeemer Hospital and Medical Center Meadowbrook Pennsylvania United States 19046
273 Riddle Memorial Hospital Media Pennsylvania United States 19063
274 Intercommunity Cancer Center Monroeville Pennsylvania United States 15146
275 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
276 Allegheny Valley Hospital Natrona Heights Pennsylvania United States 15065
277 UPMC Jameson New Castle Pennsylvania United States 16105
278 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
279 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
280 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
281 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
282 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
283 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
284 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
285 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
286 UPMC Jefferson Regional Radiation Oncology Pittsburgh Pennsylvania United States 15236
287 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
288 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
289 Penn State Health Saint Joseph Medical Center Reading Pennsylvania United States 19605
290 Grand View Hospital Sellersville Pennsylvania United States 18960
291 Mount Nittany Medical Center State College Pennsylvania United States 16803
292 Crozer-Chester Medical Center Upland Pennsylvania United States 19013
293 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
294 Reading Hospital West Reading Pennsylvania United States 19611
295 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
296 WellSpan Health-York Hospital York Pennsylvania United States 17403
297 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
298 Medical University of South Carolina Charleston South Carolina United States 29425
299 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
300 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
301 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
302 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
303 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
304 The Radiation Oncology Center-Hilton Head/Bluffton Hilton Head Island South Carolina United States 29926
305 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
306 Spartanburg Medical Center Spartanburg South Carolina United States 29303
307 Lexington Medical Center West Columbia South Carolina United States 29169
308 Rapid City Regional Hospital Rapid City South Dakota United States 57701
309 Avera Cancer Institute Sioux Falls South Dakota United States 57105
310 Texas Oncology-Arlington South Arlington Texas United States 76014
311 Texas Oncology-Austin Midtown Austin Texas United States 78705
312 Texas Oncology - South Austin Cancer Center Austin Texas United States 78745
313 Texas Oncology Bedford Bedford Texas United States 76022
314 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
315 Texas Oncology - Denison Cancer Center Denison Texas United States 75020
316 Texas Oncology-Denton South Denton Texas United States 76201
317 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
318 Texas Oncology - Fort Worth Cancer Center Fort Worth Texas United States 76104
319 Memorial Hermann Memorial City Medical Center Houston Texas United States 77024
320 Baylor Medical Center at Irving Irving Texas United States 75061
321 Texas Oncology - Lewisville Lewisville Texas United States 75067
322 West Texas Cancer Center Odessa Texas United States 79761
323 Texas Oncology-Plano West Plano Texas United States 75093
324 Texas Oncology-Seton Williamson Round Rock Texas United States 78665
325 Texas Oncology - Round Rock Cancer Center Round Rock Texas United States 78681
326 Cancer Care Centers of South Texas- Northeast San Antonio Texas United States 78217
327 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
328 Texas Oncology Cancer Center Sugar Land Sugar Land Texas United States 77479
329 Texas Oncology-Wichita Falls Texoma Cancer Center Wichita Falls Texas United States 76310
330 Logan Regional Hospital Logan Utah United States 84321
331 Intermountain Medical Center Murray Utah United States 84107
332 McKay-Dee Hospital Center Ogden Utah United States 84403
333 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
334 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
335 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
336 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
337 Inova Alexandria Hospital Alexandria Virginia United States 22304
338 University of Virginia Cancer Center Charlottesville Virginia United States 22908
339 Inova Fairfax Hospital Falls Church Virginia United States 22042
340 Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia United States 22939
341 Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia United States 23666
342 Sentara Rockingham Memorial Hospital Hahn Cancer Center Harrisonburg Virginia United States 22801
343 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
344 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
345 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
346 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
347 Harrison Medical Center Bremerton Washington United States 98310
348 Saint Francis Hospital Federal Way Washington United States 98003
349 Tri-Cities Cancer Center Kennewick Washington United States 99336
350 Skagit Valley Hospital Mount Vernon Washington United States 98274
351 Virginia Mason Medical Center Seattle Washington United States 98101
352 Seattle Cancer Care Alliance Seattle Washington United States 98109
353 Olympic Medical Cancer Care Center Sequim Washington United States 98384
354 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
355 Cancer Care Northwest-North Spokane Spokane Washington United States 99218
356 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
357 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
358 West Virginia University Healthcare Morgantown West Virginia United States 26506
359 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
360 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
361 ThedaCare Regional Medical Center - Appleton Appleton Wisconsin United States 54911
362 Beloit Memorial Hospital Beloit Wisconsin United States 53511
363 Mayo Clinic Health System Eau Claire Hospital-Luther Campus Eau Claire Wisconsin United States 54703
364 Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin United States 54935
365 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
366 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
367 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
368 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
369 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
370 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
371 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
372 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
373 Bay Area Medical Center Marinette Wisconsin United States 54143
374 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
375 Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin United States 53097
376 Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin United States 53211
377 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
378 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
379 Ascension All Saints Hospital Racine Wisconsin United States 53405
380 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
381 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
382 Aurora Medical Center in Summit Summit Wisconsin United States 53066
383 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
384 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
385 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
386 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
387 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
388 BCCA-Vancouver Cancer Centre Vancouver British Columbia Canada V5Z 4E6
389 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
390 Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
391 Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario Canada N2G 1G3
392 London Regional Cancer Program London Ontario Canada N6A 4L6
393 Stronach Regional Health Centre at Southlake Newmarket Ontario Canada L3Y 2P9
394 Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario Canada K1H 8L6
395 Ottawa Hospital-Civic Campus Ottawa Ontario Canada K1Y 4E9
396 Irving Greenberg Family Cancer Centre Ottawa Ontario Canada K2H 8P4
397 Windsor Regional Cancer Centre Windsor Ontario Canada N8W 2X3
398 Hopital de la Cite-de-la-Sante Laval Quebec Canada H7M 3L9
399 CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
400 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
401 McGill University Department of Oncology Montreal Quebec Canada H2W 1S6
402 CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4
403 The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec Canada H3H 2R9
404 CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec Canada G1R 2J6
405 Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec Canada J1H 5N4
406 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
407 Pamela Youde Nethersole Eastern Hospital Chai Wan Hong Kong
408 Rabin Medical Center Petach Tikva Israel 49100
409 Chaim Sheba Medical Center Tel Hashomer Israel 52621
410 Shizuoka Cancer Center Shizuoka City Suntou Japan 411-8777
411 National Cancer Center-Korea Goyang-si Gyeonggi-do Korea, Republic of 410-769
412 Yonsei University Health System-Severance Hospital Seoul Korea, Republic of 120-752
413 National University Hospital Singapore Singapore Singapore 119074
414 National Cancer Centre Singapore Singapore Singapore 169610
415 Kantonsspital Aarau Aarau Switzerland 5001

Sponsors and Collaborators

  • Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01349322
Other Study ID Numbers:
  • RTOG-1005
  • NCI-2011-02669
  • CDR0000700069
  • NCT03553797
First Posted:
May 6, 2011
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022

Study Results

No Results Posted as of Apr 8, 2022