Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2001
End Date:April 2004

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A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells
and prevent recurrence of the cancer.

PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy
and radiation therapy in treating patients who have stage I rectal cancer.

OBJECTIVES:

- Determine the overall, disease-free, and colostomy-free survival rates in patients with
stage I rectal cancer treated with local excision with or without adjuvant chemotherapy
and radiotherapy.

- Determine the local, regional, and distant recurrence rates in patients treated with
these regimens.

- Determine whether loco-regional recurrences after local excision can be successfully
salvaged with radical surgery with or without adjuvant therapy for permanent cure in
patients treated with these regimens.

- Determine whether the analysis of certain histological and molecular markers can help
determine prognosis in patients treated with these regimens.

- Determine the anorectal, urinary, and sexual function effects in patients treated with
these regimens.

- Determine the non-functional treatment morbidity and mortality exclusive of anorectal,
urinary, and sexual function effects in patients treated with these regimens.

- Determine the overall survival of patients with pathology exclusions undergoing local
excision.

- Determine the efficacy of the current standard in detecting recurrence during
follow-up, including office visits, blood tests, and proctoscopy in patients treated
with these regimens.

OUTLINE: This is a multicenter study.

All patients undergo full thickness disc excision. Patients with T3 disease or positive
surgical margins after surgery are removed from study. Patients with T1 disease and negative
surgical margins after surgery are observed. Patients with T2 disease and negative surgical
margins after surgery receive adjuvant therapy.

Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours
with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks.
Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy
comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while
receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy,
patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once
weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the rectum

- T1 or T2 by physical and endoscopic exams

- No T3 lesions by clinical or radiological exam

- Villous adenomas or in situ carcinoma allowed without histologicalconfirmation
if clinical appearance of cancer

- No multi-focal disease within the rectum at time of initial diagnosis

- No non-adenocarcinomatous rectal cancer or anal cancer

- Less than 4 cm at greatest diameter

- Less than 40% of rectal wall circumference involved

- Proximal margin no greater than 8 cm from dentate line

- No tumor fixation to the perirectal tissues regardless of size

- No malignant regional lymph node or distant metastases by clinical exam
orradiographical imaging

- No palpable perirectal lymph nodes or nodes larger than 1 cm

- No evidence of malignant perirectal lymph nodes by endorectal ultrasound
orendorectal MRI

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CTC 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times normal

Renal:

- Creatinine less than 1.8 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior or concurrent malignancy within the past 5 years except inactive
nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- No prior surgery for rectal cancer including prior attempts at transanal or
transcoccygeal surgical excision with unclear or positive margins

- Prior incision or operative biopsy or colonoscopic removal allowed
We found this trial at
179
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New Orleans, Louisiana 70112
2099
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New Orleans, LA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
2485
mi
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
2110
mi
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Buffalo, NY
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
1733
mi
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Chicago, IL
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
2016
mi
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Cleveland, OH
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
1932
mi
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Detroit, MI
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
960
mi
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Duarte, CA
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
2341
mi
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Durham, NC
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
1786
mi
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Fort Sam Houston, TX
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
1935
mi
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Galveston, TX
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
2227
mi
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Greenville, SC
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
2679
mi
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Honolulu, HI
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
1983
mi
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Jackson, MS
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
1780
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Little Rock, AR
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979
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Los Angeles, CA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
962
mi
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Los Angeles, CA
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
959
mi
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Los Angeles, CA
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300 Community Drive
Manhasset, New York 11030
2414
mi
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Manhasset, NY
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
2414
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Manhasset, NY
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
2732
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Miami Beach, FL
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
628
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Sacramento, CA
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
1780
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San Antonio, TX
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2351
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Albany, NY
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Albuquerque, New Mexico 87108
1187
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Albuquerque, NM
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Albuquerque, New Mexico 87131
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Albuquerque, NM
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Amarillo, Texas 79106
1356
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Amarillo, TX
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1356
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Amarillo, TX
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1902
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Ann Arbor, MI
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
1898
mi
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Ann Arbor, MI
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
1903
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Ann Arbor, MI
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2118
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Anniston, AL
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Asheville, North Carolina 28805
2190
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Asheville, NC
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Atlanta, Georgia 30342
2174
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Baltimore, MD
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Baltimore, MD
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Bennington, Vermont 05201
2372
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Bennington, VT
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
1609
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Bettendorf, IA
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Billings, Montana 59101
667
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Billings, MT
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Biloxi, Mississippi 39531
2125
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02118
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2112
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Burlington, Vermont 05405
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Burlington, VT
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
2375
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Chapel Hill, North Carolina 27599
2337
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Chapel Hill, NC
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Charleston, South Carolina 29401
2424
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
2422
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Charleston, SC
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Charlottesville, Virginia 22901
2285
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1730
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Chicago, IL
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1737
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Chicago, Illinois 60640
1728
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Chicago, IL
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3200 Vine Street
Cincinnati, Ohio 45220
1966
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Cincinnati, Ohio 45267
1966
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Cincinnati, OH
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1611
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Columbia, MO
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Columbia, Missouri 65203
1611
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
2008
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Columbus, OH
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2006
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Columbus, OH
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Concord, North Carolina 28025
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Concord, NC
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1684
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Dallas, TX
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1957
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Dayton, OH
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Dayton, Ohio 45420
1959
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Decatur, Illinois 62526
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Denver, Colorado 80010
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1932
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Detroit, MI
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
1930
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Detroit, MI
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Durham, North Carolina 27705
2338
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Elmhurst, New York 11373
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Fargo, North Dakota 58102
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Fayetteville, North Carolina 28304
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Fort Gordon, Georgia 30905
2295
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Fort Lauderdale, Florida 33316
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1875
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Fort Wayne, IN
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100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
1794
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Grand Rapids, MI
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Hines, IL
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Hollywood, FL
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Honolulu, Hawaii 96813
2679
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
2933
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
1892
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Houston, TX
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Houston, TX
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Huntington, West Virginia 25702
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Iowa City, Iowa 52242
1557
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Iowa City, IA
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Jackson, Mississippi 39216
1983
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Jackson, MS
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Jamaica, New York 11432
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Jamaica Plain, MA
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
1495
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Kansas City, Missouri 64128
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Kansas City, Missouri 64131
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Keesler AFB, Mississippi 39534
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Keesler AFB, MS
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Kinston, North Carolina 28503
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La Jolla, California 92093
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Las Vegas, NV
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Lebanon, New Hampshire 03756
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2007
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Lexington, KY
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Los Angeles, CA
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Louisville, Kentucky 40207
1944
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