Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01242800
Collaborator
National Cancer Institute (NCI) (NIH)
391
377
2
136.7
1
0

Study Details

Study Description

Brief Summary

RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer.

PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: palliative surgery
  • Procedure: therapeutic conventional surgery
  • Radiation: palliative radiation therapy
  • Radiation: radiation therapy
N/A

Detailed Description

OBJECTIVES:

Primary

  • To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival.

Secondary

  • To compare the time to uncontrolled chest wall disease between patients treated with these regimens.

  • To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients treated with these regimens.

  • To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival).

  • To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.

  • Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.

Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies.

Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
391 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
Actual Study Start Date :
Feb 8, 2011
Actual Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I

Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.

Procedure: palliative surgery
Undergo standard palliative surgery

Radiation: palliative radiation therapy
Undergo standard palliative radiotherapy

Experimental: Arm II

Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.

Procedure: therapeutic conventional surgery
Undergo early surgery

Radiation: radiation therapy
Undergo radiotherapy

Outcome Measures

Primary Outcome Measures

  1. Overall survival [Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years]

    Overall survival, defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact.

Secondary Outcome Measures

  1. Uncontrolled chest wall disease [Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years]

    The chest wall/breast will be called "controlled" if there is no clinical or radiological evidence of the local tumor; or if there is evidence of the primary tumor but no skin nodules, ulceration, or chest wall fixation. Time to uncontrolled chest wall disease is defined as time from randomization to the development of uncontrolled chest wall disease. Patients with controlled chest wall will be censored at the last date of evaluation.

  2. Health-related quality of life [Assessed at baseline, randomization, 6, 18 and 30 months after randomization]

    The FACT-Breast Trial Outcome Index will be used as the primary HRQL endpoint. FACT-B TOI scores at baseline, randomization, 6, 18 and 30 months after randomization will be calculated and compared for participants randomized to early local therapy versus palliative local therapy. The change of FACT-B TOI scores over time will be compared between treatment arms as well. For the palliative local therapy arm, the change of QOL from randomization to the time of decision for local therapy will also be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast

  • Stage IV disease

  • Confirmation of the primary tumor should be by needle biopsy (preferred)

  • Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast

  • Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)

  • For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)

  • Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence

  • Prior ipsilateral invasive cancer allowed if more than 5 years previous

  • No synchronous contralateral breast cancer

  • Patients should have at least one organ system involved with distant metastatic disease

  • If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available

  • Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy

  • CNS metastases allowed provided projected survival > 6 months

  • Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)

  • If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible

  • Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)

  • Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed

  • Patients must be randomized within 16-32 weeks after the start of systemic therapy

  • Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/- 2 weeks prior to randomization, including:

  • No new sites of disease

  • No enlargement of existing sites by 20% or more in longest diameter

  • No symptomatic deterioration

  • Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible

  • Local disease at the primary site must be asymptomatic

  • Hormone receptor status known

PATIENT CHARACTERISTICS:
  • See Disease Characteristics

  • Menopausal status not specified

  • Patients must have adequate organ function to undergo local therapy 4 weeks +/- 2 weeks prior to randomization per investigator discretion and institutional guidelines

  • More than 5 years since other primary cancers that were curatively treated

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use an accepted and effective contraception method

PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36604
2 Providence Cancer Center Anchorage Alaska United States 99508
3 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259-5499
4 East Bay Radiation Oncology Center Castro Valley California United States 94546
5 Enloe Cancer Center at Enloe Medical Center Chico California United States 95926
6 North Bay Cancer Center Fairfield California United States 94533
7 California Cancer Care, Incorporated - Greenbrae Greenbrae California United States 94904
8 Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach California United States 90806
9 Contra Costa Regional Medical Center Martinez California United States 94553-3156
10 Community Hospital of the Monterey Peninsula Comprehensive Cancer Center Monterey California United States 93940
11 El Camino Hospital Cancer Center Mountain View California United States 94040
12 CCOP - Bay Area Tumor Institute Oakland California United States 94609
13 St. Joseph Hospital Regional Cancer Center - Orange Orange California United States 92868
14 Doctors Medical Center - San Pablo Campus San Pablo California United States 94806
15 Stanford Cancer Center Stanford California United States 94305-5824
16 Boulder Community Hospital Boulder Colorado United States 80301-9019
17 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
18 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
19 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
20 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
21 Norwalk Hospital Norwalk Connecticut United States 06856
22 Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut United States 06360
23 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
24 CCOP - Christiana Care Health Services Newark Delaware United States 19713
25 Herbert D. Kerman Regional Oncology Center - Daytona Beach Daytona Beach Florida United States 32114
26 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
27 Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida United States 32803-1273
28 M.D. Anderson Cancer Center at Orlando Orlando Florida United States 32806
29 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
30 Georgia Cancer Center for Excellence at Grady Memorial Hospital Atlanta Georgia United States 30303
31 Emory Crawford Long Hospital Atlanta Georgia United States 30308
32 Piedmont Hospital Atlanta Georgia United States 30309
33 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
34 Northside Hospital Cancer Center Atlanta Georgia United States 30342-1611
35 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342-1701
36 John B. Amos Cancer Center Columbus Georgia United States 31904
37 Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia United States 30033
38 Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia United States 30060
39 Southern Regional Medical Center Riverdale Georgia United States 30274-2600
40 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia United States 31405
41 Kapiolani Medical Center at Pali Momi 'Aiea Hawaii United States 96701
42 Leeward Radiation Oncology 'Ewa Beach Hawaii United States 96706
43 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
44 Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii United States 96813
45 Straub Clinic and Hospital, Incorporated Honolulu Hawaii United States 96813
46 Hawaii Medical Center - East Honolulu Hawaii United States 96817
47 Kuakini Medical Center Honolulu Hawaii United States 96817
48 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
49 Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho United States 83712
50 Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho United States 83619
51 Mountain States Tumor Institute - Meridian Meridian Idaho United States 83642
52 Saint Luke's Mountain States Tumor Institute Nampa Idaho United States 83686
53 Mountain States Tumor Institute at St. Luke's Twin Falls Idaho United States 83301
54 St. Joseph Medical Center Bloomington Illinois United States 61701
55 Graham Hospital Canton Illinois United States 61520
56 Memorial Hospital Carthage Illinois United States 62321
57 Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois United States 60611-3013
58 Hematology and Oncology Associates Chicago Illinois United States 60611
59 John H. Stroger, Jr. Hospital of Cook County Chicago Illinois United States 60612-3785
60 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
61 Resurrection Medical Center Chicago Illinois United States 60631
62 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
63 Louis A. Weiss Memorial Hospital Chicago Illinois United States 60640
64 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
65 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
66 Eureka Community Hospital Eureka Illinois United States 61530
67 Galesburg Clinic, PC Galesburg Illinois United States 61401
68 Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois United States 60426
69 Kellogg Cancer Care Center Highland Park Illinois United States 60035
70 Hinsdale Hematology Oncology Associates Hinsdale Illinois United States 60521
71 Provena St. Mary's Regional Cancer Center - Kankakee Kankakee Illinois United States 60901
72 North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois United States 60048
73 McDonough District Hospital Macomb Illinois United States 61455
74 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
75 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois United States 61265
76 Cancer Care and Hematology Specialists of Chicagoland - Niles Niles Illinois United States 60714
77 BroMenn Regional Medical Center Normal Illinois United States 61761
78 Community Cancer Center Normal Illinois United States 61761
79 Community Hospital of Ottawa Ottawa Illinois United States 61350
80 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
81 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
82 Proctor Hospital Peoria Illinois United States 61614
83 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
84 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
85 Methodist Medical Center of Illinois Peoria Illinois United States 61636
86 OSF St. Francis Medical Center Peoria Illinois United States 61637
87 Illinois Valley Community Hospital Peru Illinois United States 61354
88 West Suburban Center for Cancer Care River Forest Illinois United States 60305
89 Swedish-American Regional Cancer Center Rockford Illinois United States 61104-2315
90 Hematology Oncology Associates - Skokie Skokie Illinois United States 60076
91 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
92 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
93 Elkhart General Hospital Elkhart Indiana United States 46515
94 Center for Cancer Care at Goshen General Hospital Goshen Indiana United States 46526
95 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202-5289
96 William N. Wishard Memorial Hospital Indianapolis Indiana United States 46202
97 Howard Community Hospital Kokomo Indiana United States 46904
98 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
99 Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana United States 46545-1470
100 Saint Joseph Regional Medical Center Mishawaka Indiana United States 46545-1470
101 Reid Hospital & Health Care Services Richmond Indiana United States 47374
102 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
103 Memorial Hospital of South Bend South Bend Indiana United States 46601
104 McFarland Clinic, PC Ames Iowa United States 50010
105 Medical Oncology and Hematology Associates - West Des Moines Clive Iowa United States 50325
106 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
107 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
108 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
109 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
110 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
111 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
112 McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa United States 52501
113 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
114 Mercy Medical Center - Sioux City Sioux City Iowa United States 51102
115 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
116 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
117 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
118 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
119 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
120 Cancer Center of Kansas-Independence Independence Kansas United States 67301
121 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
122 Lawrence Memorial Hospital Lawrence Kansas United States 66044
123 Cancer Center of Kansas, PA - Liberal Liberal Kansas United States 67901
124 Cancer Center of Kansas, PA - McPherson McPherson Kansas United States 67460
125 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
126 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
127 CCOP - Kansas City Prairie Village Kansas United States 66208
128 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
129 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67401
130 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
131 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
132 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
133 CCOP - Wichita Wichita Kansas United States 67214
134 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
135 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
136 St. Elizabeth Medical Center Edgewood Kentucky United States 41017
137 Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky United States 40536-0093
138 Tulane Cancer Center Office of Clinical Research Alexandria Louisiana United States 71315-3198
139 DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis Maryland United States 21401
140 Greater Baltimore Medical Center Cancer Center Baltimore Maryland United States 21204
141 St. Agnes Hospital Cancer Center Baltimore Maryland United States 21229
142 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
143 Shore Regional Cancer Center at Memorial Hospital - Easton Easton Maryland United States 21601
144 Union Hospital of Cecil County Elkton Maryland United States 21921
145 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
146 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
147 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
148 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
149 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
150 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
151 Genesys Hurley Cancer Institute Flint Michigan United States 48503
152 Hurley Medical Center Flint Michigan United States 48503
153 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
154 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
155 Dickinson County Healthcare System Iron Mountain Michigan United States 49801
156 Foote Memorial Hospital Jackson Michigan United States 49201
157 Borgess Medical Center Kalamazoo Michigan United States 49001
158 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
159 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
160 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
161 St. Mary Mercy Hospital Livonia Michigan United States 48154
162 MidMichigan Medical Center - Midland Midland Michigan United States 48670
163 Community Cancer Center of Monroe Monroe Michigan United States 48162
164 Mercy Memorial Hospital - Monroe Monroe Michigan United States 48162
165 Mercy General Health Partners Muskegon Michigan United States 49444
166 St. Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
167 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
168 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
169 William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan United States 48073
170 Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan United States 48601
171 Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan United States 49085
172 Lakeside Cancer Specialists, PLLC Saint Joseph Michigan United States 49085
173 Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan United States 48075
174 Munson Medical Center Traverse City Michigan United States 49684
175 St. John Macomb Hospital Warren Michigan United States 48093
176 Fairview Ridges Hospital Burnsville Minnesota United States 55337
177 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
178 Fairview Southdale Hospital Edina Minnesota United States 55435
179 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
180 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
181 Immanuel St. Joseph's Mankato Minnesota United States 56002
182 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
183 Minnesota Oncology - Maplewood Maplewood Minnesota United States 55109
184 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota United States 55407
185 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
186 New Ulm Medical Center New Ulm Minnesota United States 56073
187 Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota United States 55422-2900
188 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
189 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
190 Park Nicollet Cancer Center Saint Louis Park Minnesota United States 55416
191 Regions Hospital Cancer Care Center Saint Paul Minnesota United States 55101
192 United Hospital Saint Paul Minnesota United States 55102
193 St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota United States 55379
194 Lakeview Hospital Stillwater Minnesota United States 55082
195 Ridgeview Medical Center Waconia Minnesota United States 55387
196 Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota United States 56201
197 Minnesota Oncology - Woodbury Woodbury Minnesota United States 55125
198 University of Mississippi Cancer Clinic Jackson Mississippi United States 39216
199 Regional Cancer Center at Singing River Hospital Pascagoula Mississippi United States 39581
200 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
201 Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri United States 64111
202 Research Medical Center Kansas City Missouri United States 64132
203 Mercy Clinic Cancer and Hematology - Rolla Rolla Missouri United States 65401
204 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
205 Saint Joseph Oncology, Incorporated Saint Joseph Missouri United States 64507
206 St. Anthony's Cancer Center Saint Louis Missouri United States 63128
207 David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri United States 63141
208 St. John's Regional Health Center Springfield Missouri United States 65804
209 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
210 CCOP - Montana Cancer Consortium Billings Montana United States 59101
211 Billings Clinic - Downtown Billings Montana United States 59107-7000
212 Big Sky Oncology Great Falls Montana United States 59405-5309
213 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
214 Sletten Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
215 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
216 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
217 Immanuel Medical Center Omaha Nebraska United States 68122
218 Lakeside Hospital Omaha Nebraska United States 68130
219 Creighton University Medical Center Omaha Nebraska United States 68131-2197
220 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
221 Norris Cotton Cancer Center at Catholic Medical Center Manchester New Hampshire United States 03102
222 Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington New Jersey United States 08822
223 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey United States 08053
224 Newark Beth Israel Medical Center Newark New Jersey United States 07112
225 Radiation Oncology Center at Kennedy Health System - Sewell Sewell New Jersey United States 08080
226 J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River New Jersey United States 08755
227 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
228 Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey United States 08043
229 Lovelace Medical Center - Downtown Albuquerque New Mexico United States 87102
230 University of New Mexico Cancer Center Albuquerque New Mexico United States 87131-5636
231 University of New Mexico Cancer Center - South Las Cruces New Mexico United States 88011
232 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
233 Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown New York United States 13326
234 Winthrop University Hospital Mineola New York United States 11501
235 Beth Israel Medical Center - Petrie Division New York New York United States 10003-3803
236 St. Luke's - Roosevelt Hospital Center - St.Luke's Division New York New York United States 10025
237 Mount Sinai Medical Center New York New York United States 10029
238 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
239 Dyson Center for Cancer Care at Vassar Brothers Medical Center Poughkeepsie New York United States 12601-3990
240 Highland Hospital of Rochester Rochester New York United States 14620
241 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
242 Nalitt Cancer Institute at Staten Island University Hospital Staten Island New York United States 10305
243 Dickstein Cancer Treatment Center at White Plains Hospital Center White Plains New York United States 10601
244 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
245 Batte Cancer Center at Northeast Medical Center Concord North Carolina United States 28025
246 Iredell Memorial Hospital Statesville North Carolina United States 28677
247 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
248 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
249 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
250 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
251 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
252 Trinity CancerCare Center Minot North Dakota United States 58701
253 McDowell Cancer Center at Akron General Medical Center Akron Ohio United States 44307
254 Summa Center for Cancer Care at Akron City Hospital Akron Ohio United States 44309-2090
255 Wood County Oncology Center Bowling Green Ohio United States 43402
256 Case Comprehensive Cancer Center Cleveland Ohio United States 44106-5065
257 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
258 CCOP - Columbus Columbus Ohio United States 43215
259 Grant Medical Center Cancer Care Columbus Ohio United States 43215
260 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
261 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
262 Good Samaritan Hospital Dayton Ohio United States 45406
263 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
264 Samaritan North Cancer Care Center Dayton Ohio United States 45415
265 Grady Memorial Hospital Delaware Ohio United States 43015
266 Community Cancer Center Elyria Ohio United States 44035
267 Hematology Oncology Center Elyria Ohio United States 44035
268 Blanchard Valley Medical Associates Findlay Ohio United States 45840
269 Middletown Regional Hospital Franklin Ohio United States 45005-1066
270 Fairfield Medical Center Lancaster Ohio United States 43130
271 Lima Memorial Hospital Lima Ohio United States 45804
272 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
273 Northwest Ohio Oncology Center Maumee Ohio United States 43537-1839
274 Knox Community Hospital Mount Vernon Ohio United States 43050
275 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
276 St. Charles Mercy Hospital Oregon Ohio United States 43616
277 Toledo Clinic - Oregon Oregon Ohio United States 43616
278 Southern Ohio Medical Center Cancer Center Portsmouth Ohio United States 45662
279 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
280 Flower Hospital Cancer Center Sylvania Ohio United States 43560
281 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
282 Toledo Hospital Toledo Ohio United States 43606
283 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
284 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
285 CCOP - Toledo Community Hospital Toledo Ohio United States 43617
286 St. Anne Mercy Hospital Toledo Ohio United States 43623
287 Toledo Clinic, Incorporated - Main Clinic Toledo Ohio United States 43623
288 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
289 Fulton County Health Center Wauseon Ohio United States 43567
290 Mount Carmel St. Ann's Cancer Center Westerville Ohio United States 43081
291 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
292 Oklahoma University Cancer Institute Oklahoma City Oklahoma United States 73104
293 St. Luke's Cancer Network at St. Luke's Hospital Bethlehem Pennsylvania United States 18015
294 Easton Regional Cancer Center at Easton Hospital Easton Pennsylvania United States 18042
295 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
296 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
297 Lancaster General Hospital Lancaster Pennsylvania United States 17604
298 St. Mary Regional Cancer Center Langhorne Pennsylvania United States 19047
299 Lewistown Hospital Lewistown Pennsylvania United States 17044
300 Charles A. & Betty Bott Cancer Center at Holy Redeemer Hospital Meadowbrook Pennsylvania United States 19046
301 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
302 Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania United States 19111-2497
303 UPMC Cancer Centers Pittsburgh Pennsylvania United States 15232
304 Mount Nittany Medical Center State College Pennsylvania United States 16803
305 Susquehanna Cancer Center at Divine Providence Hospital Williamsport Pennsylvania United States 17701
306 York Cancer Center at Apple Hill Medical Center York Pennsylvania United States 17405
307 Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina United States 29401
308 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
309 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
310 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
311 Avera Cancer Institute Sioux Falls South Dakota United States 57105
312 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
313 West Tennessee Cancer Center at Jackson-Madison County General Hospital Jackson Tennessee United States 38301
314 University of Texas Medical Branch Galveston Texas United States 77555-0361
315 M. D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
316 Methodist Hospital Houston Texas United States 77030
317 Baylor Medical Center at Irving Irving Texas United States 75061
318 Doctor's Hospital of Laredo Laredo Texas United States 78045
319 CCOP - Scott and White Hospital Temple Texas United States 76508
320 Huntsman Cancer Institute at University of Utah Salt Lake City Utah United States 84112
321 Fredericksburg Oncology, Incorporated Fredericksburg Virginia United States 22401
322 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037
323 St. Joseph Cancer Center Bellingham Washington United States 98225
324 Harrison Medical Center Bremerton Washington United States 98310
325 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington United States 98122-4307
326 University Cancer Center at University of Washington Medical Center Seattle Washington United States 98195
327 St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla Washington United States 99362
328 St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington West Virginia United States 25702
329 Langlade Memorial Hospital Antigo Wisconsin United States 54409
330 Fox Valley Hematology and Oncology - East Grant Street Appleton Wisconsin United States 54911-3496
331 Fox Valley Surgical Associates at Appleton Medical Center Appleton Wisconsin United States 54911
332 Theda Care Cancer Institute Appleton Wisconsin United States 54911
333 Marshfield Clinic - Chippewa Center Chippewa Falls Wisconsin United States 54729
334 Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire Wisconsin United States 54701
335 Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin United States 54701
336 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
337 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
338 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
339 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
340 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
341 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
342 Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin United States 54601
343 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
344 Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin United States 54221-1450
345 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
346 Vince Lombardi Cancer Clinic - Marinette Marinette Wisconsin United States 54143
347 Saint Joseph's Hospital Marshfield Wisconsin United States 54449
348 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
349 Marshfield Clinic - Lakeland Center Minocqua Wisconsin United States 54548
350 Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
351 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
352 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
353 Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin United States 54501
354 Marshfield Clinic - Indianhead Center Rice Lake Wisconsin United States 54868
355 St. Nicholas Hospital Sheboygan Wisconsin United States 53081
356 Vince Lombardi Cancer Clinic - Sheboygan Sheboygan Wisconsin United States 53081
357 Marshfield Clinic at Saint Michael's Hospital Stevens Point Wisconsin United States 54481
358 Saint Michael's Hospital Cancer Center Stevens Point Wisconsin United States 54481
359 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
360 Aurora Medical Center Summit Wisconsin United States 53066
361 Vince Lombardi Cancer Clinic - Two Rivers Two Rivers Wisconsin United States 54241
362 Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin United States 53188
363 Marshfield Clinic - Wausau Center Wausau Wisconsin United States 54401
364 University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau Wisconsin United States 54401
365 Oncology Alliance, SC - Milwaukee - West Wauwatosa Wisconsin United States 53226
366 Diagnostic and Treatment Center Weston Wisconsin United States 54476
367 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
368 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
369 Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids Wisconsin United States 54494
370 Cross Cancer Institute at University of Alberta Edmonton Alberta Canada T6G 1Z2
371 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
372 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
373 London Regional Cancer Program at London Health Sciences Centre London Ontario Canada N6A 4L6
374 McGill Cancer Centre at McGill University Montreal Quebec Canada H2W 1S6
375 Tel-Aviv Sourasky Medical Center Tel Aviv Israel 64239
376 King Faisal Specialist Hospital and Research Center Riyadh Saudi Arabia 11211
377 Pretoria Academic Hospital Pretoria South Africa 0002

Sponsors and Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Seema A. Khan, MD, Robert H. Lurie Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01242800
Other Study ID Numbers:
  • CDR0000688097
  • ECOG-E2108
First Posted:
Nov 17, 2010
Last Update Posted:
Dec 22, 2021
Last Verified:
May 1, 2021
Keywords provided by Eastern Cooperative Oncology Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2021