Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
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Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
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Determine the toxicity of topical sunscreen vs placebo in these patients.
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Determine whether discontinuation of treatment intervention is followed by rash development.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
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Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.
Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
After completion of study treatment, patients are followed for 8 weeks.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: sunscreen Patients apply sunscreen generously to the entire body twice daily for 4 weeks. Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks. After completion of study treatment, patients are followed for 8 weeks. |
Drug: sunscreen
|
Placebo Comparator: placebo Patients apply placebo generously to the entire body twice daily for 4 weeks. Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks. After completion of study treatment, patients are followed for 8 weeks. |
Other: placebo
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of rash development by Skindex questionnaire [Up to 8 weeks]
Secondary Outcome Measures
- Toxicity by NCI CTCAE v3.0 [Up to 8 weeks]
- Rash incidence at 4 and 8 weeks [Up to 8 weeks]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of cancer
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Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
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Gefitinib
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Cetuximab
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Erlotinib
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Panitumumab
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ICR-62
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Matuzumab
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CI-1033
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EGFR treatment must have begun within the past 3 days
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No rash (of any etiology) at study entry
PATIENT CHARACTERISTICS:
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Able to apply sunscreen on face, trunk, and extremities
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Able to complete questionnaire(s)
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No history of allergic reactions or severe intolerance to sunscreen or its derivatives
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No history of skin problems likely to reoccur during treatment
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Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily
PRIOR CONCURRENT THERAPY:
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See Disease Characteristics
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No concurrent tanning bed usage
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No other concurrent topical sunscreens
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
2 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60507 |
3 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
4 | Graham Hospital | Canton | Illinois | United States | 61520 |
5 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
6 | St. Anthony's Memorial Hospital | Effingham | Illinois | United States | 62401 |
7 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
8 | Galesburg Clinic | Galesburg | Illinois | United States | 61401 |
9 | Galesburg Cottage Hospital | Galesburg | Illinois | United States | 61401 |
10 | Mason District Hospital | Havana | Illinois | United States | 62644 |
11 | Hopedale Medical Complex | Hopedale | Illinois | United States | 61747 |
12 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
13 | Kewanee Hospital | Kewanee | Illinois | United States | 61443 |
14 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
15 | Trinity Medical Center - East | Moline | Illinois | United States | 61265 |
16 | Moline | Illinois | United States | 61265 | |
17 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
18 | Community Cancer Center | Normal | Illinois | United States | 61761 |
19 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
20 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
21 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
22 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
23 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
24 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
25 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
26 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
27 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
28 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
29 | St. Margaret's Hospital | Spring Valley | Illinois | United States | 61362 |
30 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
31 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
32 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
33 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
34 | Howard Community Hospital at Howard Regional Health System | Kokomo | Indiana | United States | 46904 |
35 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
36 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
37 | Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | United States | 47374 |
38 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
39 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
40 | Saint Joseph Regional Medical Center | South Bend | Indiana | United States | 46617 |
41 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
42 | Bettendorf | Iowa | United States | 52722 | |
43 | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | United States | 52403 |
44 | Mercy Capitol Hospital | Des Moines | Iowa | United States | 50307 |
45 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
46 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
47 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
48 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
49 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
50 | John Stoddard Cancer Center | Des Moines | Iowa | United States | 50316-2301 |
51 | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | United States | 50401 |
52 | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | United States | 52501 |
53 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
54 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
55 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
56 | Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa | United States | 50266 |
57 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
58 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
59 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
60 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
61 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
62 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
63 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
64 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
65 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
66 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
67 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67203 |
68 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
69 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
70 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
71 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
72 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
73 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
74 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
75 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
76 | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48123-2500 |
77 | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | United States | 49431 |
78 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
79 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
80 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
81 | Dickinson County Healthcare System | Iron Mountain | Michigan | United States | 49801 |
82 | Foote Hospital | Jackson | Michigan | United States | 49201 |
83 | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | United States | 48144 |
84 | Sparrow Regional Cancer Center | Lansing | Michigan | United States | 48909 |
85 | Community Cancer Center of Monroe | Monroe | Michigan | United States | 48162 |
86 | Mercy Memorial Hospital - Monroe | Monroe | Michigan | United States | 48162 |
87 | Seton Cancer Institute - Saginaw | Saginaw | Michigan | United States | 48601 |
88 | Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | St. Joseph | Michigan | United States | 49085 |
89 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
90 | MeritCare Clinic - Bemidji | Bemidji | Minnesota | United States | 56601 |
91 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
92 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
93 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
94 | Miller-Dwan Medical Center | Duluth | Minnesota | United States | 55805 |
95 | St. Mary's - Duluth Clinic Cancer Center | Duluth | Minnesota | United States | 55805 |
96 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
97 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
98 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
99 | Meeker County Memorial Hospital | Lichfield | Minnesota | United States | 55355 |
100 | Immanuel St. Joseph's Clinic | Mankato | Minnesota | United States | 56002 |
101 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
102 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
103 | Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
104 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
105 | Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale | Minnesota | United States | 55422-2900 |
106 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
107 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
108 | Saint Francis Cancer Center | Shakopee | Minnesota | United States | 55379 |
109 | St. Joseph's Hospital | St Paul | Minnesota | United States | 55102 |
110 | Park Nicollet Health Services | St. Louis Park | Minnesota | United States | 55416 |
111 | Regions Hospital Cancer Care Center | St. Paul | Minnesota | United States | 55101 |
112 | United Hospital | St. Paul | Minnesota | United States | 55102 |
113 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
114 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
115 | Woodwinds Health Campus | Woodbury | Minnesota | United States | 55125 |
116 | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri | United States | 63141 |
117 | Missouri Baptist Cancer Center | St. Louis | Missouri | United States | 63131 |
118 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
119 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59101 |
120 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
121 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
122 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
123 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
124 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
125 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
126 | Great Falls | Montana | United States | 59405 | |
127 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
128 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
129 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
130 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
131 | Community Medical Center | Missoula | Montana | United States | 59801 |
132 | Guardian Oncology and Center for Wellness | Missoula | Montana | United States | 59804 |
133 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
134 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
135 | Cancer Resource Center - Lincoln | Lincoln | Nebraska | United States | 68510 |
136 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
137 | Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
138 | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
139 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131-2197 |
140 | Rutherford Hospital | Rutherfordton | North Carolina | United States | 28139 |
141 | Bismarck Cancer Center | Bismarck | North Dakota | United States | 58501 |
142 | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | United States | 58501 |
143 | Mid Dakota Clinic, PC | Bismarck | North Dakota | United States | 58501 |
144 | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | United States | 58502 |
145 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
146 | MeritCare Broadway | Fargo | North Dakota | United States | 58122 |
147 | Wood County Oncology Center | Bowling Green | Ohio | United States | 43402 |
148 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
149 | Riverside Methodist Hospital Cancer Care | Columbus | Ohio | United States | 43214-3998 |
150 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
151 | Grant Medical Center Cancer Care | Columbus | Ohio | United States | 43215 |
152 | Mount Carmel Health - West Hospital | Columbus | Ohio | United States | 43222 |
153 | Doctors Hospital at Ohio Health | Columbus | Ohio | United States | 43228 |
154 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
155 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
156 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
157 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
158 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
159 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
160 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
161 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
162 | Fremont Memorial Hospital | Fremont | Ohio | United States | 43420 |
163 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
164 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
165 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
166 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
167 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537 |
168 | St. Luke's Hospital | Maumee | Ohio | United States | 43537 |
169 | Middletown Regional Hospital | Middletown | Ohio | United States | 45044 |
170 | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
171 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
172 | Toledo Clinic - Oregon | Oregon | Ohio | United States | 43616 |
173 | Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
174 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
175 | Mercy Medical Center | Springfield | Ohio | United States | 45504 |
176 | Community Hospital of Springfield and Clark County | Springfield | Ohio | United States | 45505 |
177 | Flower Hospital Cancer Center | Sylvania | Ohio | United States | 43560 |
178 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
179 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
180 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
181 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
182 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43617 |
183 | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | United States | 43623 |
184 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
185 | Fulton County Health Center | Wauseon | Ohio | United States | 43567 |
186 | Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville | Ohio | United States | 43081 |
187 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
188 | Genesis - Good Samaritan Hospital | Zanesville | Ohio | United States | 43701 |
189 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
190 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-0001 |
191 | Geisinger Medical Group - Scenery Park | State College | Pennsylvania | United States | 16801 |
192 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
193 | AnMed Cancer Center | Anderson | South Carolina | United States | 29621 |
194 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
195 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
196 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
197 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
198 | Medical X-Ray Center, PC | Sioux Falls | South Dakota | United States | 57105 |
199 | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
200 | Hematology-Oncology Associates of Fredericksburg, Incorporated | Fredericksburg | Virginia | United States | 22401 |
201 | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54301-3526 |
202 | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
203 | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | United States | 54303 |
204 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
205 | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | United States | 54143 |
206 | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | United States | 54154 |
207 | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235 |
208 | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Aminah Jatoi, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
- NCCTG-N05C4
- NCI-2012-02700
- CDR0000492254