Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01556243
Collaborator
National Cancer Institute (NCI) (NIH)
270
350
1
0.8

Study Details

Study Description

Brief Summary

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

Condition or Disease Intervention/Treatment Phase
  • Procedure: therapeutic conventional surgery
  • Radiation: whole breast irradiation
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).

Secondary

  • To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.

  • To assess whether patients who did not undergo re-excision for close margins (< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved.

  • To assess patient's perception of cosmesis and incidence of breast lymphedema.

  • To assess incidence of breast lymphedema

  • To examine the type and severity of adverse effects of breast conserving surgery and radiation for women with multiple ipsilateral primary breast cancer (MIBC).

  • To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.

OUTLINE: This is a multicenter study.

Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.

Study Design

Study Type:
Interventional
Actual Enrollment :
270 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breast conservation surgery and radiation therapy

Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.

Procedure: therapeutic conventional surgery

Radiation: whole breast irradiation

Outcome Measures

Primary Outcome Measures

  1. Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years [Up to 5 years post-treatment]

Secondary Outcome Measures

  1. Conversion rate to mastectomy secondary to persistent positive margins assessed [Up to 5 years post-treatment]

  2. Type and severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [Up to 30 days post-treatment]

  3. Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0 [Up to 30 days post-treatment]

  4. Patient's perception of cosmesis assessed up to 24 months after WBI using the BREAST-Q© scoring module [Up to 2 years post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Registration Inclusion Criteria:
  1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.

  2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)

  3. Female Gender - Men are excluded from this study. Male breast cancer is a rare event.

Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

  1. Foci of Breast Cancer

4.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue.

4.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).

No more than 2 quadrants with biopsy proven breast cancer.

4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.

4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).

4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only.

4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy.

4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.

  1. Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:

5.1 An area of atypia > 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC. OR

5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology.

  1. Mammogram Imaging - Bilateral mammogram ≤ 90 days prior to date of surgery.

6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment.

  1. Staging of Cancer - cN0 or cN1 disease

  2. ECOG Performance Status (PS) - 0, 1, or 2.

  3. Ability to Complete Questionnaires - Ability to complete questionnaire(s) by themselves or with assistance

  4. Ability to Provide Written Informed Consent

  5. Willing to Return to Enrolling Institution - Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.

Registration Exclusion Criteria:
  1. Pregnancy, Nursing and Requirement for Contraception - Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation.

This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.

  1. Size of Single Focus of Disease on Preoperative Imaging - Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion.

  2. Prior Staging Procedure - Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted.

  3. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease

  4. Prior History of Breast Cancer - Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]

  5. Staging of Cancer - cNX, cN2, or cN3 disease

  6. Breast Implants - Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible.

  7. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).

  8. Uncontrolled Intercurrent Illness - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

  9. Bilateral Breast Cancer - Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).

  10. Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed). Patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy.

  11. Partial Breast Radiation - Planned partial breast radiation.

  12. Known BRCA Mutations - Patients with known BRCA mutations. Patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study.

  13. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.

14.2 Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
2 Epic Care-Dublin Dublin California United States 94568
3 Bay Area Breast Surgeons, Incorporated Emeryville California United States 94608
4 Epic Care Partners in Cancer Care Emeryville California United States 94608
5 UC San Diego Moores Cancer Center La Jolla California United States 92093
6 Cedars Sinai Medical Center Los Angeles California United States 90048
7 Cedars-Sinai Medical Center Los Angeles California United States 90048
8 Contra Costa Regional Medical Center Martinez California United States 94553
9 Alta Bates Summit Medical Center-Summit Campus Oakland California United States 94609
10 Bay Area Tumor Institute Oakland California United States 94609
11 Stanford Cancer Institute Palo Alto California United States 94304
12 Naval Medical Center-San Diego San Diego California United States 92134-3202
13 University of Colorado Cancer Center-Anschutz Cancer Pavilion Aurora Colorado United States 80045
14 Catholic Health Initiatives NCORP Englewood Colorado United States 80112
15 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
16 Beebe Medical Center Lewes Delaware United States 19958
17 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
18 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
19 Helen F. Graham Cancer Center Newark Delaware United States 19713
20 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
21 Regional Hematology and Oncology PA Newark Delaware United States 19713
22 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
23 Beebe Health Campus Rehoboth Beach Delaware United States 19971
24 Nanticoke Memorial Hospital Seaford Delaware United States 19973
25 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
26 Morton Plant Hospital Clearwater Florida United States 33756
27 Mount Sinai Medical Center Miami Beach Florida United States 33140
28 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
29 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
30 Oncare Hawaii, Incorporated-Pali Momi 'Aiea Hawaii United States 96701
31 Pali Momi Medical Center 'Aiea Hawaii United States 96701
32 The Cancer Center of Hawaii-Leeward 'Ewa Beach Hawaii United States 96706
33 Oncare Hawaii Inc-POB II Honolulu Hawaii United States 96813
34 Queen's Medical Center Honolulu Hawaii United States 96813
35 Straub Clinic and Hospital Honolulu Hawaii United States 96813
36 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
37 Kuakini Medical Center Honolulu Hawaii United States 96817
38 OnCare Hawaii, Incorporated-Kuakini Honolulu Hawaii United States 96817
39 OnCare Hawaii-Liliha Honolulu Hawaii United States 96817
40 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
41 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
42 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
43 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
44 Kootenai Medical Center Coeur d'Alene Idaho United States 83814
45 Kootenai Cancer Center Post Falls Idaho United States 83854
46 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
47 Saint Joseph Medical Center Bloomington Illinois United States 61701
48 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
49 Illinois CancerCare-Canton Canton Illinois United States 61520
50 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
51 Illinois CancerCare-Carthage Carthage Illinois United States 62321
52 Centralia Oncology Clinic Centralia Illinois United States 62801
53 University of Illinois Chicago Illinois United States 60612
54 Cancer Care Specialists of Central Illinois Decatur Illinois United States 62526
55 Decatur Memorial Hospital Decatur Illinois United States 62526
56 Crossroads Cancer Center Effingham Illinois United States 62401
57 Illinois CancerCare-Eureka Eureka Illinois United States 61530
58 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
59 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
60 Ingalls Memorial Hospital Harvey Illinois United States 60426
61 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
62 Illinois CancerCare-Macomb Macomb Illinois United States 61455
63 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
64 Radiation Oncology of Northern Illinois Ottawa Illinois United States 61350
65 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
66 Illinois CancerCare-Pekin Pekin Illinois United States 61603
67 Methodist Medical Center of Illinois Peoria Illinois United States 61603
68 Illinois CancerCare-Peoria Peoria Illinois United States 61615
69 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
70 OSF Saint Francis Medical Center Peoria Illinois United States 61637
71 Illinois CancerCare-Peru Peru Illinois United States 61354
72 Valley Radiation Oncology Peru Illinois United States 61354
73 Illinois CancerCare-Princeton Princeton Illinois United States 61356
74 Central Illinois Hematology Oncology Center Springfield Illinois United States 62702
75 Southern Illinois University School of Medicine Springfield Illinois United States 62702
76 Springfield Clinic Springfield Illinois United States 62703
77 Memorial Medical Center Springfield Illinois United States 62781
78 Cancer Care Specialists of Illinois-Swansea Swansea Illinois United States 62226
79 IU Health West Hospital Avon Indiana United States 46123
80 IU Health North Hospital Carmel Indiana United States 46032
81 IU Health Central Indiana Cancer Centers-Fishers Fishers Indiana United States 46037
82 Indiana University-Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
83 IU Health Methodist Hospital Indianapolis Indiana United States 46202
84 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
85 Memorial Regional Cancer Center-Day Road Mishawaka Indiana United States 46544
86 Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana United States 46545
87 Memorial Hospital of South Bend South Bend Indiana United States 46601
88 Michiana Hematology Oncology PC-South Bend South Bend Indiana United States 46601
89 Mary Greeley Medical Center Ames Iowa United States 50010
90 McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa United States 50010
91 McFarland Clinic PC-Boone Boone Iowa United States 50036
92 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
93 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
94 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
95 Greater Regional Medical Center Creston Iowa United States 50801
96 Iowa Methodist Medical Center Des Moines Iowa United States 50309
97 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
98 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
99 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
100 Mercy Medical Center-Des Moines Des Moines Iowa United States 50314
101 Iowa Lutheran Hospital Des Moines Iowa United States 50316
102 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
103 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
104 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
105 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
106 Methodist West Hospital West Des Moines Iowa United States 50266
107 Menorah Medical Center Overland Park Kansas United States 66209
108 Saint Luke's South Hospital Overland Park Kansas United States 66213
109 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
110 Flaget Memorial Hospital Bardstown Kentucky United States 40004
111 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
112 Saint Elizabeth Medical Center South Edgewood Kentucky United States 41017
113 Saint Elizabeth-Fort Thomas Fort Thomas Kentucky United States 41075
114 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
115 Saint Joseph Hospital East Lexington Kentucky United States 40509
116 Jewish Hospital Louisville Kentucky United States 40202
117 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
118 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
119 Jewish Hospital Medical Center Northeast Louisville Kentucky United States 40245
120 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
121 Eastern Maine Medical Center Bangor Maine United States 04401
122 Eastern Maine Medical Center Cancer Care Brewer Maine United States 04412
123 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
124 Saint Agnes Hospital Baltimore Maryland United States 21229
125 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
126 Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts United States 02190
127 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
128 Bronson Battle Creek Battle Creek Michigan United States 49017
129 Oakwood Hospital and Medical Center Dearborn Michigan United States 48124
130 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
131 Saint John Hospital and Medical Center Detroit Michigan United States 48236
132 Genesys Hurley Cancer Institute Flint Michigan United States 48503
133 Hurley Medical Center Flint Michigan United States 48503
134 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
135 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
136 Allegiance Health Jackson Michigan United States 49201
137 Borgess Medical Center Kalamazoo Michigan United States 49001
138 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
139 West Michigan Cancer Center Kalamazoo Michigan United States 49007
140 Sparrow Hospital Lansing Michigan United States 48912
141 Saint Mary Mercy Hospital Livonia Michigan United States 48154
142 Mercy Health Mercy Campus Muskegon Michigan United States 49444
143 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
144 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
145 Saint Mary's of Michigan Saginaw Michigan United States 48601
146 Munson Medical Center Traverse City Michigan United States 49684
147 William Beaumont Hospital-Troy Troy Michigan United States 48098
148 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
149 Fairview Ridges Hospital Burnsville Minnesota United States 55337
150 Mercy Hospital Coon Rapids Minnesota United States 55433
151 Fairview-Southdale Hospital Edina Minnesota United States 55435
152 Unity Hospital Fridley Minnesota United States 55432
153 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
154 Saint John's Hospital-Healtheast Maplewood Minnesota United States 55109
155 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
156 Hennepin County Medical Center Minneapolis Minnesota United States 55415
157 Health Partners Inc Minneapolis Minnesota United States 55454
158 New Ulm Medical Center New Ulm Minnesota United States 56073
159 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
160 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
161 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
162 Saint Cloud Hospital Saint Cloud Minnesota United States 56303
163 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
164 Park Nicollet Clinic-Saint Louis Park Saint Louis Park Minnesota United States 55416
165 Regions Hospital Saint Paul Minnesota United States 55101
166 United Hospital Saint Paul Minnesota United States 55102
167 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
168 Lakeview Hospital Stillwater Minnesota United States 55082
169 Ridgeview Medical Center Waconia Minnesota United States 55387
170 Rice Memorial Hospital Willmar Minnesota United States 56201
171 Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota United States 55125
172 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
173 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
174 Southeast Cancer Center Cape Girardeau Missouri United States 63703
175 Centerpoint Medical Center LLC Independence Missouri United States 64057
176 Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri United States 65109
177 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
178 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
179 Research Medical Center Kansas City Missouri United States 64132
180 Saint Luke's East-Lee's Summit Lee's Summit Missouri United States 64086
181 Liberty Radiation Oncology Center Liberty Missouri United States 64068
182 Washington University School of Medicine Saint Louis Missouri United States 63110
183 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
184 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
185 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
186 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
187 Montana Cancer Consortium NCORP Billings Montana United States 59101
188 Saint Vincent Healthcare Billings Montana United States 59101
189 Billings Clinic Cancer Center Billings Montana United States 59107
190 Bozeman Deaconess Hospital Bozeman Montana United States 59715
191 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
192 Benefis Healthcare-Sletten Cancer Institute Great Falls Montana United States 59405
193 Saint Peter's Community Hospital Helena Montana United States 59601
194 Kalispell Regional Medical Center Kalispell Montana United States 59901
195 Community Medical Hospital Missoula Montana United States 59801
196 Saint Patrick Hospital-Community Hospital Missoula Montana United States 59802
197 CHI Health Saint Francis Grand Island Nebraska United States 68803
198 Heartland Hematology and Oncology Kearney Nebraska United States 68845
199 CHI Health Good Samaritan Kearney Nebraska United States 68847
200 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
201 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
202 Hematology and Oncology Consultants PC Omaha Nebraska United States 68122
203 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
204 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
205 Creighton University Medical Center Omaha Nebraska United States 68131
206 Midlands Community Hospital Papillion Nebraska United States 68046
207 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
208 Comprehensive Cancer Centers of Nevada-Henderson Henderson Nevada United States 89052
209 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
210 21st Century Oncology-Henderson Henderson Nevada United States 89074
211 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
212 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
213 Cancer and Blood Specialists-Shadow Las Vegas Nevada United States 89106
214 Nevada Cancer Research Foundation NCORP Las Vegas Nevada United States 89106
215 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
216 21st Century Oncology-Fort Apache Las Vegas Nevada United States 89109
217 21st Century Oncology Las Vegas Nevada United States 89109
218 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
219 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
220 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
221 Cancer Therapy and Integrative Medicine Las Vegas Nevada United States 89121
222 21st Century Oncology-Vegas Tenaya Las Vegas Nevada United States 89128
223 Cancer and Blood Specialists-Tenaya Las Vegas Nevada United States 89128
224 Comprehensive Cancer Centers of Nevada-Northwest Las Vegas Nevada United States 89128
225 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
226 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
227 Cancer and Blood Specialists-Fort Apache Las Vegas Nevada United States 89148
228 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
229 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148
230 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
231 Comprehensive Cancer Centers of Nevada-Central Valley Las Vegas Nevada United States 89169
232 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
233 Memorial Sloan Kettering Cancer Center-Basking Ridge Basking Ridge New Jersey United States 07920
234 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
235 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
236 Lovelace Women's Hospital Albuquerque New Mexico United States 87109
237 Memorial Sloan Kettering Cancer Center-Commack Commack New York United States 11725
238 Memorial Sloan Kettering Cancer Center-West Harrison Harrison New York United States 10604
239 North Shore University Hospital Manhasset New York United States 11030
240 North Shore-LIJ Health System/Center for Advanced Medicine New Hyde Park New York United States 11040
241 Memorial Sloan Kettering Cancer Center New York New York United States 10065
242 Vassar Brothers Medical Center Poughkeepsie New York United States 12601
243 University of Rochester Rochester New York United States 14642
244 Memorial Sloan Kettering Cancer Center-Rockville Centre Rockville Centre New York United States 11570
245 Memorial Sloan Kettering Cancer Center-Sleepy Hollow Sleepy Hollow New York United States 10591
246 Randolph Hospital Asheboro North Carolina United States 27203
247 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
248 Levine Cancer Institute-Tryon Charlotte North Carolina United States 28203
249 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
250 Carolina Surgical Clinic of Charlotte PA Charlotte North Carolina United States 28207
251 Oncology Specialists of Charlotte Charlotte North Carolina United States 28207
252 Carolinas Medical Center/Levine Cancer Institute-Pineville Charlotte North Carolina United States 28210
253 Carolinas Medical Center/Levine Cancer Institute-University Charlotte North Carolina United States 28262
254 Southern Oncology Specialists-Charlotte Charlotte North Carolina United States 28262
255 Levine Cancer Institute-Ballantyne Charlotte North Carolina United States 28277
256 CaroMont Breast Surgical Specialists-Gastonia Gastonia North Carolina United States 28054
257 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
258 Cone Health Cancer Center Greensboro North Carolina United States 27403
259 Lake Norman Hematology Oncology Specialists-Huntersville Huntersville North Carolina United States 28078
260 Southern Oncology Specialists-Huntersville Huntersville North Carolina United States 28078
261 Matthews Radiation Oncology Center Matthews North Carolina United States 28105
262 Novant Health Cancer Specialists-Matthews Matthews North Carolina United States 28105
263 Carolinas HealthCare System Union Monroe North Carolina United States 28112
264 Lake Norman Hematology Oncology Specialists-Mooresville Mooresville North Carolina United States 28117
265 Annie Penn Memorial Hospital Reidsville North Carolina United States 27320
266 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
267 Adena Regional Medical Center Chillicothe Ohio United States 54601
268 The Christ Hospital Cincinnati Ohio United States 45219
269 Good Samaritan Hospital-Cincinnati Cincinnati Ohio United States 45220
270 Bethesda North Hospital Cincinnati Ohio United States 45242
271 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
272 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
273 University of Cincinnati Cincinnati Ohio United States 45267
274 Mount Carmel East Hospital Columbus Ohio United States 43213
275 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
276 Riverside Methodist Hospital Columbus Ohio United States 43214
277 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
278 Grant Medical Center Columbus Ohio United States 43215
279 The Mark H Zangmeister Center Columbus Ohio United States 43219
280 Mount Carmel Health Center West Columbus Ohio United States 43222
281 Doctors Hospital Columbus Ohio United States 43228
282 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
283 Delaware Radiation Oncology Delaware Ohio United States 43015
284 Grady Memorial Hospital Delaware Ohio United States 43015
285 Fairfield Medical Center Lancaster Ohio United States 43130
286 OhioHealth MedCentral Hospital Mansfield Ohio United States 44903
287 Marietta Memorial Hospital Marietta Ohio United States 45750
288 OhioHealth Marion General Hospital Marion Ohio United States 43302
289 Knox Community Hospital Mount Vernon Ohio United States 43050
290 Licking Memorial Hospital Newark Ohio United States 43055
291 Newark Radiation Oncology Newark Ohio United States 43055
292 Southern Ohio Medical Center Portsmouth Ohio United States 45662
293 Springfield Regional Medical Center Springfield Ohio United States 45505
294 University Pointe West Chester Ohio United States 45069
295 Saint Ann's Hospital Westerville Ohio United States 43081
296 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
297 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
298 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
299 Oregon Health and Science University Portland Oregon United States 97239
300 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
301 Lehigh Valley Hospital-Muhlenberg Bethlehem Pennsylvania United States 18017
302 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
303 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
304 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
305 Roger Williams Medical Center Providence Rhode Island United States 02908
306 Hilton Head Regional Medical Center Hilton Head Island South Carolina United States 29926
307 Levine Cancer Institute-Rock Hill Rock Hill South Carolina United States 29732
308 Lexington Medical Center West Columbia South Carolina United States 29169
309 Avera Cancer Institute Sioux Falls South Dakota United States 57105
310 Memorial Hospital Chattanooga Tennessee United States 37404
311 Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee United States 37343
312 Memorial GYN Plus Ooltewah Tennessee United States 37363
313 Texas Tech University Health Sciences Center-Amarillo Amarillo Texas United States 79106
314 Parkland Memorial Hospital Dallas Texas United States 75235
315 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
316 M. D. Anderson Cancer Center Houston Texas United States 77030
317 The Methodist Hospital System Houston Texas United States 77030
318 Doctor's Hospital of Laredo Laredo Texas United States 78045
319 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
320 Central Vermont Medical Center Berlin Vermont United States 05602
321 University of Vermont College of Medicine Burlington Vermont United States 05405
322 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
323 Mary Washington Hospital Fredericksburg Virginia United States 22401
324 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
325 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
326 Harrison Medical Center Bremerton Washington United States 98310
327 Highline Medical Center-Main Campus Burien Washington United States 98166
328 Saint Elizabeth Hospital Enumclaw Washington United States 98022
329 Saint Francis Hospital Federal Way Washington United States 98003
330 Saint Clare Hospital Lakewood Washington United States 98499
331 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
332 Virginia Mason Medical Center Seattle Washington United States 98101
333 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
334 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
335 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301
336 Saint Vincent Hospital Green Bay Wisconsin United States 54301
337 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
338 Saint Mary's Hospital Green Bay Wisconsin United States 54303
339 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311-6519
340 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
341 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
342 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
343 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
344 Westfields Hospital/Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
345 Vince Lombardi Cancer Clinic-Oshkosh Oshkosh Wisconsin United States 54904
346 Aurora Medical Center in Summit Summit Wisconsin United States 53066
347 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
348 Big Horn Basin Cancer Center Cody Wyoming United States 82414
349 Billings Clinic-Cody Cody Wyoming United States 82414
350 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Judy Boughey, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01556243
Other Study ID Numbers:
  • ACOSOG-Z11102
  • ACOSOG-Z11102
  • CDR0000728605
  • NCI-2012-00707
First Posted:
Mar 16, 2012
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022