Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00007007
Collaborator
National Cancer Institute (NCI) (NIH)
59
241
1
49
0.2
0

Study Details

Study Description

Brief Summary

RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the effects of the treatment and may help improve cancer treatment.

PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation therapy for brain metastases.

Condition or Disease Intervention/Treatment Phase
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
N/A

Detailed Description

OBJECTIVES: I. Determine the feasibility of performing a test battery consisting of five neurocognitive measures and a quality of life instrument following radiotherapy in patients with brain metastases.

OUTLINE: Patients undergo radiotherapy 5 days a week for 3 weeks. Quality of life and neurocognitive function is assessed before study, at completion of radiotherapy, and at 1 month after completion of radiotherapy. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases
Study Start Date :
Nov 1, 2000
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Whole brain radiation therapy + neurocognitive assessments

Whole brain radiation therapy (WBRT) with neurocognitive assessments done pre and post WBRT.

Procedure: management of therapy complications

Procedure: quality-of-life assessment

Outcome Measures

Primary Outcome Measures

  1. Feasibility of performing a test battery of neurocognitive and quality of life measures [From registration to one month post radiation therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

DISEASE CHARACTERISTICS: Histologically proven primary malignancy No primary site of hematopoietic origin (leukemia) No leptomeningeal involvement At least 1 measurable brain metastasis by CT or MRI

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy:

At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Neurological function classification 0-2 No major medical illnesses or psychiatric impairments that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified

Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain Surgery:

Not specified

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
2 Huntsville Hospital System Huntsville Alabama United States 35801-4470
3 Comprehensive Cancer Institute of Huntsville Huntsville Alabama United States 35801
4 MBCCOP - Gulf Coast Mobile Alabama United States 36688
5 Alabama Oncology, LLC Montgomery Alabama United States 36106-2801
6 Radiation Oncology Associates of West Alabama Tuscaloosa Alabama United States 35401
7 Providence Alaska Medical Center Anchorage Alaska United States 99508
8 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
9 Arizona Cancer Center Tucson Arizona United States 85724
10 Mount Diablo Medical Center Concord California United States 94524-4110
11 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
12 California Cancer Center Fresno California United States 93720
13 Saint Agnes Cancer Center Fresno California United States 93720
14 Glendale Memorial Hospital and Health Center Glendale California United States 91204
15 Sutter Health Western Division Cancer Research Group Greenbrae California United States 94904
16 University of California San Diego Cancer Center La Jolla California United States 92093-0658
17 Loma Linda University Medical Center Loma Linda California United States 92354
18 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
19 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
20 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
21 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
22 Cancer Care Center Pomona California United States 91767
23 Radiation Oncology Center - Sacramento Sacramento California United States 95816
24 Radiation Medical Group, Inc. San Diego California United States 92101-1492
25 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
26 O'Connor Hospital San Jose California United States 95128
27 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
28 David Grant Medical Center Travis Air Force Base California United States 94535
29 Memorial Hospital Cancer Center Colorado Springs Colorado United States 80909
30 University of Colorado Cancer Center Denver Colorado United States 80010
31 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
32 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
33 Lykes Center for Radiation Therapy Clearwater Florida United States 33757-0210
34 Halifax Medical Center Daytona Beach Florida United States 32114
35 Radiation Therapy Associates - Fort Myers Fort Myers Florida United States 33901
36 University of Florida Health Science Center Gainesville Florida United States 32610-0296
37 Health First Holmes Regional Medical Center Melbourne Florida United States 32901
38 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
39 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
40 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
41 Baptist Hospital of Miami Miami Florida United States 33176-2197
42 Florida Radiation Oncology Group Orange Park Florida United States 32073
43 MD Anderson Cancer Center Orlando Orlando Florida United States 32806
44 Bay Medical Center Panama City Florida United States 32401
45 Gulf Coast Cancer Treatment Center Panama City Florida United States 32405-4587
46 Sarasota Radiation and Medical Oncology Center Sarasota Florida United States 34233
47 Tallahassee Memorial Healthcare Tallahassee Florida United States 32308
48 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
49 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
50 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
51 Medical Center/John B. Amos Community Cancer Center Columbus Georgia United States 31902
52 InterCommunity Cancer Center at Rome Rome Georgia United States 30161
53 MBCCOP - Hawaii Honolulu Hawaii United States 96813
54 Northwest Community Hospital Arlington Heights Illinois United States 60005
55 Northwestern Memorial Hospital Chicago Illinois United States 60611
56 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
57 CCOP - Central Illinois Decatur Illinois United States 62526
58 Provena St. Joseph Hospital- Regional Cancer Care Center Elgin Illinois United States 60123
59 Ingalls Memorial Hospital Harvey Illinois United States 60426
60 Loyola University Medical Center Maywood Illinois United States 60153
61 Lutheran General Cancer Care Center Park Ridge Illinois United States 60068
62 Methodist Medical Center of Illinois Peoria Illinois United States 61636
63 St. John's Medical Center Anderson Indiana United States 46016
64 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
65 Clarion Health Partners Inc. Indianapolis Indiana United States 46206-1367
66 Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis Indiana United States 46219
67 Ball Memorial Hospital Muncie Indiana United States 47303-3499
68 Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa United States 52001
69 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
70 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
71 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
72 James Graham Brown Cancer Center Louisville Kentucky United States 40202
73 Louisville Radiation Oncology Louisville Kentucky United States 40215
74 Merle M. Mahr Cancer Center Madisonville Kentucky United States 42431
75 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
76 Romagosa Radiation Oncology Center Lafayette Louisiana United States 70501
77 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
78 Tulane University School of Medicine New Orleans Louisiana United States 70112
79 CCOP - Ochsner New Orleans Louisiana United States 70121
80 Maine Medical Center Portland Maine United States 04102
81 Anne Arundel Oncology Center Annapolis Maryland United States 21401
82 Greater Baltimore Medical Center and Cancer Center Baltimore Maryland United States 21204
83 Harbor Hospital Center Baltimore Maryland United States 21225
84 Sinai Hospital of Baltimore Baltimore Maryland United States 21225
85 Johns Hopkins Oncology Center Baltimore Maryland United States 21231-2410
86 Radiation Oncology Affiliates of Maryland, P.A. Baltimore Maryland United States 21237
87 Peninsula Regional Medical Center Salisbury Maryland United States 21801
88 Cape Cod Hospital Hyannis Massachusetts United States 02601
89 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
90 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
91 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
92 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
93 Henry Ford Hospital Detroit Michigan United States 48202
94 McLaren Regional Cancer Center Flint Michigan United States 48432
95 Hurley Medical Center Flint Michigan United States 48503
96 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
97 Marquette General Hospital Marquette Michigan United States 49855
98 MidMichigan Medical Center - Midland Midland Michigan United States 48670
99 William Beaumont Hospital Royal Oak Michigan United States 48073
100 St. Mary's Medical Center Saginaw Michigan United States 48601
101 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
102 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
103 North Mississippi Medical Center/Cancer Center Tupelo Mississippi United States 38801
104 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
105 CCOP - Kansas City Kansas City Missouri United States 64131
106 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
107 Mallinckrodt Institute of Radiology Saint Louis Missouri United States 63110
108 Cancer Research for the Ozarks Springfield Missouri United States 65807
109 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
110 CCOP - Montana Cancer Consortium Billings Montana United States 59101
111 Nebraska Health System Omaha Nebraska United States 68105-1018
112 Methodist Cancer Center - Omaha Omaha Nebraska United States 68114
113 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
114 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
115 Elliot Regional Cancer Center Manchester New Hampshire United States 03103
116 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
117 John F. Kennedy Medical Center Edison New Jersey United States 08818
118 Trinitas Hospital - Jersey Street Campus Elizabeth New Jersey United States 07201
119 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
120 South Jersey Regional Cancer Center Millville New Jersey United States 08332
121 Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly New Jersey United States 08060
122 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
123 Newark Beth Israel Medical Center Newark New Jersey United States 07112
124 Atlantic City Medical Center Pomona New Jersey United States 08240
125 Community Medical Center Toms River New Jersey United States 08755
126 St. Francis Medical Center Trenton New Jersey United States 08629
127 Associated Radiologists, P.A. Warren New Jersey United States 07059
128 Saint Joseph Medical Center Albuquerque New Mexico United States 87102
129 Cancer Center of Albany Medical Center Albany New York United States 12208
130 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
131 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
132 New York Methodist Hospital Brooklyn New York United States 11215-3609
133 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
134 Finger Lakes Radiation Oncology, P.C. Clifton Springs New York United States 14432
135 CCOP - North Shore University Hospital Manhasset New York United States 11030
136 Beth Israel Medical Center New York New York United States 10003
137 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
138 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
139 Champlain Valley Physicians Hospital Medical Center Plattsburgh New York United States 12901
140 Vassar Brothers Hospital Poughkeepsie New York United States 12601
141 University of Rochester Cancer Center Rochester New York United States 14642
142 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
143 New York Medical College Valhalla New York United States 10595
144 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
145 Northeast Medical Center Concord North Carolina United States 28025
146 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
147 Catawba Memorial Hospital Hickory North Carolina United States 28601
148 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
149 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
150 Meritcare Roger Maris Cancer Center Fargo North Dakota United States 58122
151 Akron General Medical Center Akron Ohio United States 44302
152 Akron City Hospital Akron Ohio United States 44309
153 Christ Hospital Cincinnati Ohio United States 45219
154 Ireland Cancer Center Cleveland Ohio United States 44106-5065
155 University Hospitals of Cleveland Cleveland Ohio United States 44106
156 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
157 CCOP - Columbus Columbus Ohio United States 43206
158 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
159 CCOP - Dayton Kettering Ohio United States 45429
160 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
161 St. Anthony Hospital Oklahoma City Oklahoma United States 73101
162 St. John Health System Tulsa Oklahoma United States 74104
163 CCOP - Columbia River Program Portland Oregon United States 97213
164 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
165 St. Luke's Hospital Regional Cancer Center Bethlehem Pennsylvania United States 18015
166 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
167 Mercy Catholic Medical Center, Mercy Fitzgerald Divison Darby Pennsylvania United States 19023
168 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
169 Penn State Geisinger Cancer Center Hershey Pennsylvania United States 17033
170 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
171 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
172 Veterans Affairs Medical Center - Philadelphia Philadelphia Pennsylvania United States 19104
173 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
174 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
175 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141
176 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213-3489
177 Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15219
178 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
179 Reading Hospital and Medical Center Reading Pennsylvania United States 19612-6052
180 Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania United States 18501
181 Wilkes Barre General Hospital Wilkes-Barre Pennsylvania United States 18764
182 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
183 York Hospital York Pennsylvania United States 17315
184 Roger Williams Medical Center/BUSM Providence Rhode Island United States 02908-4735
185 Medical University of South Carolina Charleston South Carolina United States 29425-0721
186 CCOP - Greenville Greenville South Carolina United States 29615
187 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
188 Rapid City Regional Hospital Rapid City South Dakota United States 57709
189 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
190 University of Tennessee, Memphis Cancer Center Memphis Tennessee United States 38103
191 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
192 Harrington Cancer Center Amarillo Texas United States 79106
193 Julie and Ben Rogers Cancer Institute Beaumont Texas United States 77701
194 University of Texas Medical Branch Galveston Texas United States 77555-0209
195 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
196 Wilford Hall - 59th Medical Wing Lackland Air Force Base Texas United States 78236-5300
197 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410-1894
198 East Texas Medical Center - Cancer Institute Tyler Texas United States 75701
199 Dixie Regional Medical Center Saint George Utah United States 84770
200 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
201 LDS Hospital Salt Lake City Utah United States 84143
202 CCOP - Southwestern Vermont Regional Cancer Center Bennington Vermont United States 05201
203 Vermont Cancer Center Burlington Vermont United States 05401-3498
204 Martha Jefferson Hospital Charlottesville Virginia United States 22901
205 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
206 RMH Regional Canter Center Harrisonburg Virginia United States 22801
207 Virginia Mason Medical Center Seattle Washington United States 98111
208 Deaconess Medical Center Spokane Washington United States 99210-0248
209 Yakima Valley Memorial Hospital Yakima Washington United States 98902
210 Schiffler Cancer Center Wheeling West Virginia United States 26003
211 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
212 Gundersen Lutheran Medical Foundation La Crosse Wisconsin United States 54601
213 Southern Wisconsin Radiotherapy Center Madison Wisconsin United States 53713
214 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
215 Marshfield Clinic Marshfield Wisconsin United States 54449
216 Community Memorial Hospital Menomonee Falls Wisconsin United States 53051
217 St. Joseph's Hospital Milwaukee Wisconsin United States 53210
218 Columbia Hospital Milwaukee Wisconsin United States 53211
219 St. Luke's Medical Center Milwaukee Wisconsin United States 53215
220 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
221 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
222 Southeastern Wisconsin Regional Cancer Center Racine Wisconsin United States 53405
223 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
224 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
225 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
226 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6
227 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
228 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
229 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
230 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
231 Kingston Regional Cancer Centre Kingston Ontario Canada K7L 5P9
232 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
233 Ottawa Regional Cancer Centre - General Campus Ottawa Ontario Canada K1H 1C4
234 Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario Canada P3E 5J1
235 Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario Canada P7A 7T1
236 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5
237 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
238 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
239 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L-4M1
240 McGill University Montreal Quebec Canada H2W 1S6
241 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

Sponsors and Collaborators

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

Investigators

  • Study Chair: William F. Regine, MD, Lucille P. Markey Cancer Center at University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00007007
Other Study ID Numbers:
  • RTOG-BR-0018
  • CDR0000068366
First Posted:
Mar 8, 2004
Last Update Posted:
Oct 22, 2020
Last Verified:
Mar 1, 2015
Keywords provided by Radiation Therapy Oncology Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020