Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
Start Date
11/27/2024
Completion Date
4/1/2034
Summary
This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To compare radiographic progression free survival (rPFS) between the two treatment arms in the subset of aggressive variant prostate cancer - molecular-pathologic signature (AVPC-MS)-positive participants. II. If the AVPC-MS positive test is statistically significant, test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between the two treatment arms, stratified by AVPC-MS positive versus (vs.) negative. II. To compare response rates for prostate specific antigen (PSA), total alkaline phosphatase, and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two treatment arms, stratified by AVPC-MS positive vs. negative. III. To compare rPFS between the two treatment arms for the full trial. IV. To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group. V. To compare progression free survival (PFS) between the two treatment arms, stratified by AVPC-MS positive vs. negative. VI. To compare toxicities between the two arms in participants who receive any treatment on study. BANKING OBJECTIVES: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive cabazitaxel intravenously (IV) over 60 minutes on day 1 of each cycle and prednisone orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. All patients undergo blood sample collection, bone scan, computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) throughout the trial and chest radiography (x-ray) before randomization. After completion of study treatment, patients are followed every 12 weeks for 1 year after randomization, and then every 26 weeks for up to 4 years after randomization or until death, whichever occurs first.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Bone Scan
Cabazitaxel
Carboplatin
Chest Radiography
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
Prednisone
Conditions
Locations
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Fayetteville, Arkansas 72703
United States
Highlands Oncology Group - Rogers
Rogers, Arkansas 72758
United States
Highlands Oncology Group
Springdale, Arkansas 72762
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Tibor Rubin VA Medical Center
Long Beach, California 90822
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Beebe Medical Center
Lewes, Delaware 19958
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Beebe South Coastal Health Campus
Millville, Delaware 19967
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Helen F Graham Cancer Center
Newark, Delaware 19713
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Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
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Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
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Beebe Health Campus
Rehoboth Beach, Delaware 19971
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Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
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Holy Cross Hospital
Fort Lauderdale, Florida 33308
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
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Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
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Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
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Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
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Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
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Illinois CancerCare-Canton
Canton, Illinois 61520
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Memorial Hospital of Carbondale
Carbondale, Illinois 62902
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SIH Cancer Institute
Carterville, Illinois 62918
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Illinois CancerCare-Carthage
Carthage, Illinois 62321
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Centralia Oncology Clinic
Centralia, Illinois 62801
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Northwestern University
Chicago, Illinois 60611
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University of Illinois
Chicago, Illinois 60612
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
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Decatur Memorial Hospital
Decatur, Illinois 62526
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
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Illinois CancerCare-Dixon
Dixon, Illinois 61021
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Crossroads Cancer Center
Effingham, Illinois 62401
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Illinois CancerCare-Eureka
Eureka, Illinois 61530
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Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
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Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
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Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
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Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
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Illinois CancerCare-Macomb
Macomb, Illinois 61455
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Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
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HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
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Northwestern Medicine Orland Park
Orland Park, Illinois 60462
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
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Illinois CancerCare-Pekin
Pekin, Illinois 61554
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Illinois CancerCare-Peoria
Peoria, Illinois 61615
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Methodist Medical Center of Illinois
Peoria, Illinois 61636
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Illinois CancerCare-Peru
Peru, Illinois 61354
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Valley Radiation Oncology
Peru, Illinois 61354
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Illinois CancerCare-Princeton
Princeton, Illinois 61356
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Southern Illinois University School of Medicine
Springfield, Illinois 62702
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Springfield Clinic
Springfield, Illinois 62702
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Memorial Medical Center
Springfield, Illinois 62781
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
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Illinois CancerCare - Washington
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Reid Health
Richmond, Indiana 47374
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Mercy Hospital
Cedar Rapids, Iowa 52403
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Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
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Christiana Care - Union Hospital
Elkton, Maryland 21921
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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Trinity Health Medical Center - Canton
Canton, Michigan 48188
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Caro Cancer Center
Caro, Michigan 48723
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Chelsea Hospital
Chelsea, Michigan 48118
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
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Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
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Henry Ford Health Saint John Hospital
Detroit, Michigan 48236
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Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
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Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
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Genesee Hematology Oncology PC
Flint, Michigan 48503
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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Hurley Medical Center
Flint, Michigan 48503
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Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
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Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan 48236
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Henry Ford Saint John Hospital - Breast
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University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
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Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
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Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan 48044
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Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
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Hope Cancer Center
Pontiac, Michigan 48341
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Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
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Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
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MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
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Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
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MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
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Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
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Henry Ford Madison Heights Hospital - Breast
Warren, Michigan 48093
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Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
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Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
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Huron Gastroenterology PC
Ypsilanti, Michigan 48106
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
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Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
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Cambridge Medical Center
Cambridge, Minnesota 55008
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Mercy Hospital
Coon Rapids, Minnesota 55433
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Fairview Southdale Hospital
Edina, Minnesota 55435
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Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
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Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
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Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
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Hennepin County Medical Center
Minneapolis, Minnesota 55415
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Health Partners Inc
Minneapolis, Minnesota 55454
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Monticello Cancer Center
Monticello, Minnesota 55362
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New Ulm Medical Center
New Ulm, Minnesota 56073
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Fairview Northland Medical Center
Princeton, Minnesota 55371
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North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
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Regions Hospital
Saint Paul, Minnesota 55101
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United Hospital
Saint Paul, Minnesota 55102
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Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
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Lakeview Hospital
Stillwater, Minnesota 55082
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Ridgeview Medical Center
Waconia, Minnesota 55387
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Rice Memorial Hospital
Willmar, Minnesota 56201
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Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
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Fairview Lakes Medical Center
Wyoming, Minnesota 55092
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University of Mississippi Medical Center
Jackson, Mississippi 39216
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Saint Francis Medical Center
Cape Girardeau, Missouri 63703
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Southeast Cancer Center
Cape Girardeau, Missouri 63703
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Parkland Health Center - Farmington
Farmington, Missouri 63640
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
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Missouri Baptist Medical Center
St Louis, Missouri 63131
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Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
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BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
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Community Hospital of Anaconda
Anaconda, Montana 59711
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Billings Clinic Cancer Center
Billings, Montana 59101
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Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
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Benefis Sletten Cancer Institute
Great Falls, Montana 59405
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Great Falls Clinic
Great Falls, Montana 59405
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Kalispell Regional Medical Center
Kalispell, Montana 59901
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Community Medical Center
Missoula, Montana 59804
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Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
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Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
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University of Nebraska Medical Center
Omaha, Nebraska 68198
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Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
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Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
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Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
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Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
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Dayton Physician LLC - Englewood
Dayton, Ohio 45415
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Armes Family Cancer Center
Findlay, Ohio 45840
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Blanchard Valley Hospital
Findlay, Ohio 45840
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Orion Cancer Care
Findlay, Ohio 45840
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Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
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Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
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Wayne Hospital
Greenville, Ohio 45331
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Greater Dayton Cancer Center
Kettering, Ohio 45409
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Kettering Medical Center
Kettering, Ohio 45429
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Dayton Physicians LLC - Troy
Troy, Ohio 45373
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Saint Joseph Warren Hospital
Warren, Ohio 44484
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Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
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Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon 97814
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Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
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Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
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Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
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Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
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The West Clinic - Wolf River
Germantown, Tennessee 38138
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MD Anderson in The Woodlands
Conroe, Texas 77384
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Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
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M D Anderson Cancer Center
Houston, Texas 77030
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MD Anderson West Houston
Houston, Texas 77079
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MD Anderson League City
League City, Texas 77573
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MD Anderson in Sugar Land
Sugar Land, Texas 77478
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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Billings Clinic-Cody
Cody, Wyoming 82414
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Welch Cancer Center
Sheridan, Wyoming 82801
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