Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
NCT ID: NCT01004978
Last Updated: 2024-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2009-10-28
2022-12-21
Brief Summary
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Detailed Description
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I. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.
II. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the rates of toxicity related to sorafenib in combination with chemoembolization.
TERTIARY OBJECTIVES:
I. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).
II. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.
III. To determine the inter-reader concordance for response characterization at four and eight months by the European Association for the Study of Liver (EASL) criteria.
IV. To determine the value of objective tumor response at four and eight months by the EASL criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors \[RECIST\]) and OS.
V. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sorafenib tosylate orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study.
ARM II: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm I. Patients also undergo CT and MRI on study.
MAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm I and II in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (sorafenib tosylate and TACE)
Patients receive sorafenib tosylate PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo TACE comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI on study.
Cisplatin
Undergo TACE
Computed Tomography
Undergo CT scan
Doxorubicin Hydrochloride
Undergo TACE
Doxorubicin-Eluting Beads
Undergo TACE
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Mitomycin
Undergo TACE
Pharmacological Study
Correlative studies
Sorafenib Tosylate
Given PO
Arm II (placebo and TACE)
Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm I. Patients also undergo CT and MRI on study.
Cisplatin
Undergo TACE
Computed Tomography
Undergo CT scan
Doxorubicin Hydrochloride
Undergo TACE
Doxorubicin-Eluting Beads
Undergo TACE
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Mitomycin
Undergo TACE
Pharmacological Study
Correlative studies
Placebo Administration
Given PO
Interventions
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Cisplatin
Undergo TACE
Computed Tomography
Undergo CT scan
Doxorubicin Hydrochloride
Undergo TACE
Doxorubicin-Eluting Beads
Undergo TACE
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Mitomycin
Undergo TACE
Pharmacological Study
Correlative studies
Placebo Administration
Given PO
Sorafenib Tosylate
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed
* Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion \> 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)
* AFP \> 400 ng/mL AND evidence of at least one solid liver lesion \> 2 cm regardless of specific imaging characteristics on CT or MRI
* Patients must have hepatocellular carcinoma (HCC) limited to the liver; there must be no clinical or radiographic evidence of extrahepatic HCC
* Portal lymphadenopathy IS permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy
* Staging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration
* Patients must have measurable disease constituting \< 50% of liver parenchyma within 4 weeks of registration
* Patients may not have ascites detectable on physical examination
* Patients must not be candidates for curative resection, orthotopic liver transplantation, or radiofrequency ablation (RFA)
* Patients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration
* Patients may have undergone previously attempted curative liver resection
* Patients may NOT have been previously treated with brachytherapy such as yttrium-90 microsphere
* Patients may NOT have been previously treated with sorafenib, chemoembolization, or systemic chemotherapy including cytotoxic agents or molecularly targeted agents
* Branch portal vein invasion by tumor is permitted but patients with main portal vein invasion by tumor are not eligible
* Patients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration
* Serum total bilirubin =\< 2.0 mg/dL
* Alkaline phosphatase \< 5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 5 x ULN
* Serum creatinine =\< 1.5 mg/dL
* Platelet count \>= 50,000/mm\^3
* Patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
* Patients must have no clinical signs of heart failure and meet New York Heart Association functional classification I or II defined as:
* Class I - patients with no limitation of activities; they suffer no symptoms from ordinary activities
* Class II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients must have a life expectancy of at least 3 months
* Patients must not be known to be human immunodeficiency virus (HIV) positive
* Patients must not have other uncontrolled intercurrent illnesses excluding HBV or HCV, including, but not limited to: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive disorders that would limit compliance with study requirements
* Uncontrolled hypertension is defined as optimally treated baseline blood pressure that exceeds 150/90 mm Hg
* Patients must not be taking cytochrome P450 enzyme inducing drugs
* Age \>= 18 years
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
* Patients must not have an allergy to iodine or gadolinium contrast that cannot be safely controlled with premedication
* Patient must be able to swallow pills, as study medications cannot be crushed
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Al B Benson
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Marin Cancer Care Inc
Greenbrae, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Veterans Affairs Medical Center -Washington DC
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Swedish Covenant Hospital
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Saint Francis Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States
Edward Hines Jr VA Hospital
Hines, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
West Suburban Medical Center
River Forest, Illinois, United States
Swedish American Hospital
Rockford, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
HaysMed University of Kansas Health System
Hays, Kansas, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, United States
University of Kansas Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
UP Health System Marquette
Marquette, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Ascension Providence Hospitals - Southfield
Southfield, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Administration
Columbia, Missouri, United States
Truman Medical Centers
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Mount Sinai Union Square
New York, New York, United States
Veterans Affairs New York Harbor Healthcare System-Manhattan Campus
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai West
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Princeton Community Hospital
Princeton, West Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-01981
Identifier Type: REGISTRY
Identifier Source: secondary_id
ECOG-E1208
Identifier Type: -
Identifier Source: secondary_id
10-00544
Identifier Type: -
Identifier Source: secondary_id
CDR0000657952
Identifier Type: -
Identifier Source: secondary_id
E1208
Identifier Type: OTHER
Identifier Source: secondary_id
E1208
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-01981
Identifier Type: -
Identifier Source: org_study_id
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