New combo targets stubborn colon cancer
NCT ID NCT00826540
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, sorafenib and bevacizumab, in 83 people with advanced colorectal cancer that had spread and was no longer responding to standard treatments. The goal was to see if this combination could stop or slow tumor growth. Participants received both drugs, and researchers tracked how long they lived without the cancer getting worse, as well as overall survival and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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83 people
The number who actually took part.
- Started
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Sep 2009
- Finished
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Feb 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of stage IV colorectal cancer (histologic proof is not required) * Measurable disease * Spiral CT scan required for both pre- and post-treatment tumor assessments of lesions measuring 1-2 cm * Progressive disease during or within 6 months of most recent prior chemotherapy regimen (bevacizumab, fluoropyrimidine, oxaliplatin, or irinotecan-based treatment) OR considered ineligible for standard therapy * Documentation of submission of tumor material for Kirsten Rat Sarcoma (KRAS) testing available * Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab or panitumumab) required for patients with wild-type KRAS tumor * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy ≥ 6 months * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * White blood cell count (WBC) ≥ 3,400/mm³ * International normalized ratio (INR) \< 1.5 (≤ 3.0 if on anti-coagulation therapy \[e.g., warfarin or heparin\]) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if there is liver involvement) * Alkaline phosphatase ≤ 3 times ULN * Creatinine ≤ 1.5 times ULN * Urine protein:creatinine ratio \< 1 OR urine dipstick \< 2+ OR urine protein \< 1,000 mg by 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment (≥ 2 weeks after completion of treatment with sorafenib tosylate alone) * Willing to provide mandatory blood samples for translational research studies * Able to swallow whole pills * No inadequately controlled hypertension (i.e., systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg on anti-hypertensive medications) * No prior hypertensive crisis or hypertensive encephalopathy * No myocardial infarction or unstable angina within the past 6 months * No congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No hemorrhage or bleeding event \> grade 3 within the past 4 weeks * No evidence or history of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation) * No greater than normal risk of bleeding * No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia requiring anti-arrhythmic drugs * Psychiatric illness or social situations that would limit compliance with study requirements * No known HIV infection or chronic hepatitis B or C infection * No serious, non-healing wound, active ulcer, or untreated bone fracture * Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy * No significant traumatic injury within the past 4 weeks * No known or suspected allergy or hypersensitivity to any component of bevacizumab, sorafenib tosylate, or their excipients or to any other agent given in the course of this study * No malabsorption problem * None of the following within the past 6 months: * Significant vascular disease (e.g., aortic aneurysm or aortic dissection) * Peripheral arterial thrombosis * Symptomatic peripheral vascular disease * Abdominal fistula * Gastrointestinal perforation * Intra-abdominal abscess * No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix * Prior malignancy allowed provided patient is not receiving other specific treatment for that malignancy (other than hormonal therapy) * No other concurrent investigational agent for this cancer * Prior radiotherapy allowed * No prior sorafenib tosylate * No prior discontinuation of bevacizumab due to adverse events * More than 4 weeks since prior and no concurrent participation in any other experimental drug study * More than 4 weeks since prior St. John's wort or rifampin * More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy * More than 7 days since prior core biopsy or minor surgical procedure, including placement of a vascular access device * No concurrent anticoagulant, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
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Adventist Medical Center
Portland, Oregon, 97216, United States
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Allegiance Health
Jackson, Michigan, 49201, United States
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Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
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Associates In Womens Health
Wichita, Kansas, 67208, United States
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Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
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Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
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Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
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Billings Clinic
Billings, Montana, 59107-7000, United States
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Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
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Bixby Medical Center
Adrian, Michigan, 49221, United States
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Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
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Boulder Community Hospital
Boulder, Colorado, 80301, United States
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Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
-
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
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Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
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Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
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Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
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Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
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Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
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Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
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Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
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Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
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Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
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Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
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Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
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Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
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Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
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Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
-
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403, United States
-
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
-
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
-
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
-
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
-
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
-
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
-
Community Medical Hospital
Missoula, Montana, 59801, United States
-
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
-
Dayton CCOP
Dayton, Ohio, 45420, United States
-
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
-
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, 55805, United States
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Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
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Eureka Hospital
Eureka, Illinois, 61530, United States
-
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
-
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
-
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
-
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
-
Flower Hospital
Sylvania, Ohio, 43560, United States
-
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
-
Fulton County Health Center
Wauseon, Ohio, 43567, United States
-
Galesburg Clinic
Galesburg, Illinois, 61401, United States
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Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
-
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
-
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
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Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, 18201, United States
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Geisinger Medical Group
State College, Pennsylvania, 16801, United States
-
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
-
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
-
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
-
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
-
Graham Hospital Association
Canton, Illinois, 61520, United States
-
Grandview Hospital
Dayton, Ohio, 45405, United States
-
Great Falls Clinic
Great Falls, Montana, 59405, United States
-
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49431, United States
-
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
-
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
-
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
-
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
-
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
-
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
-
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
-
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
-
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
-
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
-
Hickman Cancer Center
Adrian, Michigan, 49221, United States
-
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
-
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
-
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, United States
-
Hurley Medical Center
Flint, Michigan, 48502, United States
-
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
-
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
-
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
-
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
-
Illinois Valley Hospital
Peru, Illinois, 61354, United States
-
Immanuel-Saint Joseph Hospital-Mayo Health System
Mankato, Minnesota, 56002, United States
-
Indiana University Health La Porte Hospital
La Porte, Indiana, 46350, United States
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Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
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Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
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Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309, United States
-
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
-
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
-
Kettering Medical Center
Kettering, Ohio, 45429, United States
-
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
-
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
-
Lima Memorial Hospital
Lima, Ohio, 45804, United States
-
Longmont United Hospital
Longmont, Colorado, 80501, United States
-
Mason District Hospital
Havana, Illinois, 62644, United States
-
Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic Health System Eau Claire Hospital - Luther Campus
Eau Claire, Wisconsin, 54703, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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McKee Medical Center
Loveland, Colorado, 80539, United States
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Mcdonough District Hospital
Macomb, Illinois, 61455, United States
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Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314, United States
-
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
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Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
-
Memorial Hospital
Carthage, Illinois, 62321, United States
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Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
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Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, 43623, United States
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Mercy Capitol
Des Moines, Iowa, 50307, United States
-
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
-
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
-
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
-
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
-
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
-
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
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Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
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Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
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Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
-
Miami Valley Hospital
Dayton, Ohio, 45409, United States
-
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
-
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
-
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, 54702, United States
-
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
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Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
-
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
-
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
-
Montana Cancer Specialists
Missoula, Montana, 59802, United States
-
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
-
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410, United States
-
North Colorado Medical Center
Greeley, Colorado, 80631, United States
-
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
-
North Suburban Medical Center
Thornton, Colorado, 80229, United States
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Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
-
Northern Montana Hospital
Havre, Montana, 59501, United States
-
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
-
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
-
Oakwood Hospital
Dearborn, Michigan, 48124, United States
-
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
-
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
-
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
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Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
-
Pekin Hospital
Pekin, Illinois, 61554, United States
-
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
-
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
-
Porter Adventist Hospital
Denver, Colorado, 80210, United States
-
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
-
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
-
Proctor Hospital
Peoria, Illinois, 61614, United States
-
Regions Hospital
Saint Paul, Minnesota, 55101, United States
-
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
-
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
-
Rose Medical Center
Denver, Colorado, 80220, United States
-
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
-
Saint Anthony Central Hospital
Denver, Colorado, 80204, United States
-
Saint Charles Hospital
Oregon, Ohio, 43616, United States
-
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
-
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
-
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
-
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
-
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
-
Saint John's Hospital
Springfield, Missouri, 65804, United States
-
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
-
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
-
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
-
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
-
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
-
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545-1470, United States
-
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
-
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
-
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
-
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
-
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
-
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
-
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
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Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
-
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
-
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
-
Saint Vincent Healthcare
Billings, Montana, 59101, United States
-
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
-
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
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Samaritan North Health Center
Dayton, Ohio, 45415, United States
-
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
-
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
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Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
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Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
-
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, 61265, United States
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Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101, United States
-
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
-
South Bend Clinic
South Bend, Indiana, 46617, United States
-
Sparrow Hospital
Lansing, Michigan, 48912, United States
-
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, 61265, United States
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Swedish Medical Center
Englewood, Colorado, 80110, United States
-
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
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The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
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Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
-
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537-1839, United States
-
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
-
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
-
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
-
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
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United Hospital
Saint Paul, Minnesota, 55102, United States
-
Unity Hospital
Fridley, Minnesota, 55432, United States
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University of Toledo
Toledo, Ohio, 43614, United States
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Upper Valley Medical Center
Troy, Ohio, 45373, United States
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Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
-
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
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Wayne Hospital
Greenville, Ohio, 45331, United States
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Welch Cancer Center
Sheridan, Wyoming, 82801, United States
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Wichita CCOP
Wichita, Kansas, 67214, United States
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