Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers
Study Details
Study Description
Brief Summary
RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
OBJECTIVES:
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Characterize 3 separate types of patient-reported outcomes (quality of life [e.g., generic and disease-specific], functional outcomes [e.g., bowel and sexual function and activities of daily living], and clinical symptoms [e.g., pain, fatigue]) in long-term (5+ years) survivors of colon and rectal cancers in a large national sample recruited from five National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment trials.
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Explore the degree to which patient-reported outcomes are impacted by individual characteristics (e.g., specific predisposing factors, enabling resources, and need), by health behaviors (e.g., use of services for cancer-related and non-cancer-related issues), and, when appropriate, by the specific treatments that were received.
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Examine patient-reported outcomes prior to randomization and treatment, 1 year after treatment, and in long-term follow up > 5 years after diagnosis in patients with colon cancer treated with adjuvant chemotherapy on protocols NSABP C-06 or NSABP C-07.
OUTLINE: This is a cohort, single-group, multicenter study.
Patients complete a one-time, computer-assisted telephone interview assessing their overall quality of life (QOL), disease-specific QOL, function and symptoms (including pain and fatigue), use of healthcare services, prevalence and severity of comorbidity, and demographics.
PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07 Study population to be interviewed comprises patients who were treated at least 5 years ago for colon or rectal cancer in NSABP trials R-02, R-03, C-05, C-06 or C-07 |
Other: Telephone interview
Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)
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Outcome Measures
Primary Outcome Measures
- Types of patient-reported outcomes [After all telephone interviews are completed]
Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails
- Degree to which patient-reported outcomes are impacted by individual characteristics, health behaviors, and when appropriate specific treatments that were received [After all telephone interviews are completed]
Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information
- Comparison of patient-reported outcomes prior to randomization, 1 year after completion of study treatment, and in long-term follow up > 5 years after diagnosis in patients treated in NSABP C-06 or NSABP C-07 trials [After all telephone interviews are completed]
Four generic subscales of FACT-C and the colorectal cancer subscale, total score of symptoms distress scale, SF-12 Vitality subscale and health rating scale; NTX-R
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Prior diagnosis of colon or rectal cancer
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At least 5 years since participated in 1 of the following clinical trials:
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NSABP-R-02
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NSABP-R-03
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NSABP-C-05
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NSABP-C-06
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NSABP-C-07
PATIENT CHARACTERISTICS:
- Able to speak English
PRIOR CONCURRENT THERAPY:
- As per participation requirements of previous NSABP treatment trials
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Aurora Presbyterian Hospital | Aurora | Colorado | United States | 80012 |
2 | Boulder Community Hospital | Boulder | Colorado | United States | 80301-9019 |
3 | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | United States | 80933 |
4 | St. Anthony Central Hospital | Denver | Colorado | United States | 80204 |
5 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
6 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
7 | St. Joseph Hospital | Denver | Colorado | United States | 80218 |
8 | Rose Medical Center | Denver | Colorado | United States | 80220 |
9 | CCOP - Colorado Cancer Research Program | Denver | Colorado | United States | 80224-2522 |
10 | Swedish Medical Center | Englewood | Colorado | United States | 80110 |
11 | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | United States | 81502 |
12 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
13 | Sky Ridge Medical Center | Lone Tree | Colorado | United States | 80124 |
14 | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | United States | 80502 |
15 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
16 | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | United States | 81004 |
17 | North Suburban Medical Center | Thornton | Colorado | United States | 80229 |
18 | Exempla Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
19 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
20 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
21 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
22 | Northside Hospital Cancer Center | Atlanta | Georgia | United States | 30342-1611 |
23 | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | United States | 30342-1701 |
24 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342 |
25 | WellStar Cobb Hospital | Austell | Georgia | United States | 30106 |
26 | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | United States | 30033 |
27 | Gwinnett Medical Center | Lawrenceville | Georgia | United States | 30045 |
28 | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | United States | 30060 |
29 | Southern Regional Medical Center | Riverdale | Georgia | United States | 30274-2600 |
30 | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31403-3089 |
31 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
32 | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | United States | 62002 |
33 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60504 |
34 | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | United States | 62526 |
35 | Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois | United States | 60201-1781 |
36 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
37 | Good Samaritan Regional Health Center | Mt. Vernon | Illinois | United States | 62864 |
38 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
39 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
40 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
41 | Howard Community Hospital | Kokomo | Indiana | United States | 46904 |
42 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
43 | Clarian Arnett Cancer Care | Lafayette | Indiana | United States | 47904 |
44 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
45 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
46 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
47 | Saint Joseph Regional Medical Center | South Bend | Indiana | United States | 46617 |
48 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
49 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
50 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
51 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
52 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
53 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
54 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
55 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
56 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
57 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
58 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
59 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
60 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
61 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
62 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
63 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
64 | Shawnee Mission Medical Center | Shawnee Mission | Kansas | United States | 66204 |
65 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
66 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67208 |
67 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
68 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
69 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
70 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
71 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
72 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
73 | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | United States | 40536-0093 |
74 | Louisville Oncology at Norton Cancer Institute - Louisville | Louisville | Kentucky | United States | 40202 |
75 | Ochsner Health Center - Bluebonnet | Baton Rouge | Louisiana | United States | 70809 |
76 | CCOP - Ochsner | New Orleans | Louisiana | United States | 70121 |
77 | Suburban Hospital | Bethesda | Maryland | United States | 20814 |
78 | Union Hospital Cancer Program at Union Hospital | Elkton MD | Maryland | United States | 21921 |
79 | Boston University Cancer Research Center | Boston | Massachusetts | United States | 02118 |
80 | Jordan Hospital Club Cancer Center | Plymouth | Massachusetts | United States | 02360 |
81 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
82 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
83 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
84 | Bay Regional Medical Center | Bay City | Michigan | United States | 48708 |
85 | Mecosta County Medical Center | Big Rapids | Michigan | United States | 49307 |
86 | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48123-2500 |
87 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
88 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
89 | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
90 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
91 | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
92 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
93 | Foote Memorial Hospital | Jackson | Michigan | United States | 49201 |
94 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49001 |
95 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007-3731 |
96 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
97 | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | United States | 48910 |
98 | Sparrow Regional Cancer Center | Lansing | Michigan | United States | 48912-1811 |
99 | St. Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
100 | Upper Michigan Cancer Center at Marquette General Hospital | Marquette | Michigan | United States | 49855 |
101 | Hackley Hospital | Muskegon | Michigan | United States | 49442 |
102 | St. Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341-2985 |
103 | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | United States | 48060 |
104 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
105 | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | United States | 48601 |
106 | Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph | Michigan | United States | 49085 |
107 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
108 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
109 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
110 | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | United States | 55805-1983 |
111 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
112 | Miller - Dwan Medical Center | Duluth | Minnesota | United States | 55805 |
113 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
114 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
115 | Hattiesburg Clinic, PA at Forrest General | Hattiesburg | Mississippi | United States | 39401 |
116 | Hematology & Oncology Clinic | Hattiesburg | Mississippi | United States | 39402 |
117 | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Cape Girardeau | Missouri | United States | 63701 |
118 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
119 | Independence Regional Health Center | Independence | Missouri | United States | 64050 |
120 | Truman Medical Center - Hospital Hill | Kansas City | Missouri | United States | 64108 |
121 | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
122 | St. Joseph Medical Center | Kansas City | Missouri | United States | 64114 |
123 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
124 | Parvin Radiation Oncology | Kansas City | Missouri | United States | 64116 |
125 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
126 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
127 | Liberty Hospital | Liberty | Missouri | United States | 64068 |
128 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
129 | Midwest Hematology Oncology Group, Incorporated | Saint Louis | Missouri | United States | 63109 |
130 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
131 | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri | United States | 63141 |
132 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65802 |
133 | St. John's Regional Health Center | Springfield | Missouri | United States | 65804 |
134 | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | United States | 65807 |
135 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
136 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59101 |
137 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
138 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
139 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
140 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
141 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
142 | Great Falls | Montana | United States | 59405 | |
143 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
144 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
145 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
146 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
147 | Community Medical Center | Missoula | Montana | United States | 59801 |
148 | Guardian Oncology and Center for Wellness | Missoula | Montana | United States | 59804 |
149 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
150 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
151 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
152 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
153 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
154 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
155 | Mary Rutan Hospital | Bellefontaine | Ohio | United States | 43311 |
156 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
157 | Riverside Methodist Hospital Cancer Care | Columbus | Ohio | United States | 43214-3998 |
158 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
159 | Grant Medical Center Cancer Care | Columbus | Ohio | United States | 43215 |
160 | Mount Carmel Health - West Hospital | Columbus | Ohio | United States | 43222 |
161 | Doctors Hospital at Ohio Health | Columbus | Ohio | United States | 43228 |
162 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
163 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
164 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
165 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
166 | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
167 | Mercy Medical Center | Springfield | Ohio | United States | 45504 |
168 | Community Hospital of Springfield and Clark County | Springfield | Ohio | United States | 45505 |
169 | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | United States | 43081 |
170 | Genesis - Good Samaritan Hospital | Zanesville | Ohio | United States | 43701 |
171 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
172 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
173 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
174 | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301-1792 |
175 | Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
176 | UPMC Cancer Centers | Pittsburgh | Pennsylvania | United States | 15232 |
177 | CCOP - Main Line Health | Wynnewood | Pennsylvania | United States | 19096 |
178 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
179 | McLeod Regional Medical Center | Florence | South Carolina | United States | 29501 |
180 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
181 | Medical X-Ray Center, PC | Sioux Falls | South Dakota | United States | 57105 |
182 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
183 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
184 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
185 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98104 |
186 | Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin | United States | 54701 |
187 | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | United States | 54701 |
188 | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54301-3526 |
189 | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
190 | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | United States | 54303 |
191 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
192 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449 |
193 | Saint Joseph's Hospital | Marshfield | Wisconsin | United States | 54449 |
194 | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | United States | 54548 |
195 | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | United States | 54501 |
196 | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | United States | 54868 |
197 | Saint Michael's Hospital Cancer Center | Stevens Point | Wisconsin | United States | 54481 |
198 | Marshfield Clinic - Wausau Center | Wausau | Wisconsin | United States | 54401 |
199 | Marshfield Clinic - Weston Center | Weston | Wisconsin | United States | 54476 |
200 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- NSABP Foundation Inc
- National Cancer Institute (NCI)
- University of California, Los Angeles
Investigators
- Study Chair: Norman Wolmark, MD, NSABP Foundation Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NSABP LTS-01
- CDR0000494640