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Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT01004978
Collaborator
(none)
235
Enrollment
281
Locations
2
Arms
0.8
Patients Per Site

Study Details

Study Description

Brief Summary

This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, 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. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cisplatin
  • Drug: Doxorubicin Hydrochloride
  • Drug: Doxorubicin-Eluting Beads
  • Other: Laboratory Biomarker Analysis
  • Drug: Mitomycin
  • Other: Pharmacological Study
  • Other: Placebo Administration
  • Drug: Sorafenib Tosylate
 Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.
SECONDARY OBJECTIVES:

  1. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.

  2. 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:

  1. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).

  2. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.

  3. 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.

  4. 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.

  5. 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.

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.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
235 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
Actual Study Start Date :
Oct 28, 2009
Actual Primary Completion Date :
Feb 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Cisplatin
Undergo TACE
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

    • Drug: Doxorubicin Hydrochloride
    Undergo TACE
    Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

    • Drug: Doxorubicin-Eluting Beads
    Undergo TACE

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Mitomycin
    Undergo TACE
    Other Names:
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycin
  • Mutamycine
  • NCI-C04706

    • Other: Pharmacological Study
    Correlative studies

    Drug: Sorafenib Tosylate
    Given PO
    Other Names:
  • BAY 43-9006 Tosylate
  • BAY 54-9085
  • Nexavar
  • sorafenib

    		•
    Active Comparator: 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.

    Drug: Cisplatin
    Undergo TACE
    Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

    • Drug: Doxorubicin Hydrochloride
    Undergo TACE
    Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

    • Drug: Doxorubicin-Eluting Beads
    Undergo TACE

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Mitomycin
    Undergo TACE
    Other Names:
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycin
  • Mutamycine
  • NCI-C04706

    • Other: Pharmacological Study
    Correlative studies

    Other: Placebo Administration
    Given PO

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [Time from randomization to progression or death without evidence of progression, assessed up to 16 months]

      All PFS analyses will use the multi-time point (for the vascular invasion at 4, 8 and 12 months, and the non-vascular invasion group at 8, 12 and 16 months) Cochran-Mantel-Haenszel (CMH) test of Freidlin, et al. with an overall one-sided 0.025 type I error. The p-value from the one-sided multi-time point CMH test will be compared to the truncated O'Brien-Fleming boundary.

    Secondary Outcome Measures

    1. Overall survival [Time from randomization to death from any cause, or last known date of survival, assessed up to 4 years]

      Analyses will use a one-sided logrank test stratified on vascular invasion (yes vs. no) and Child-Pugh Score (A vs. B7), using a one-sided overall type I error of 0.025. Critical values at interim analyses will be determined using a truncated version of the Lan-Demets error spending rate function corresponding to the O'Brien-Fleming boundary.

    2. Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [Up to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:

    • 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 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    3 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    4 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    5 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    6 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    7 John L McClellan Memorial Veterans Hospital Little Rock Arkansas United States 72205
    8 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    9 Marin Cancer Care Inc Greenbrae California United States 94904
    10 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    11 Saint Joseph Hospital - Orange Orange California United States 92868
    12 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    13 Zuckerberg San Francisco General Hospital San Francisco California United States 94110
    14 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    15 University of Colorado Hospital Aurora Colorado United States 80045
    16 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    17 Porter Adventist Hospital Denver Colorado United States 80210
    18 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    19 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    20 Yale University New Haven Connecticut United States 06520
    21 Beebe Medical Center Lewes Delaware United States 19958
    22 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    23 Veterans Affairs Medical Center -Washington DC Washington District of Columbia United States 20422
    24 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    25 Lakeland Regional Health Hollis Cancer Center Lakeland Florida United States 33805
    26 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    27 Medical Center of Central Georgia Macon Georgia United States 31201
    28 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    29 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    30 Queen's Medical Center Honolulu Hawaii United States 96813
    31 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    32 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    33 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    34 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    35 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    36 Castle Medical Center Kailua Hawaii United States 96734
    37 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    38 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    39 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    40 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    41 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    42 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    43 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    44 Saint Joseph Medical Center Bloomington Illinois United States 61701
    45 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    46 Graham Hospital Association Canton Illinois United States 61520
    47 Illinois CancerCare-Canton Canton Illinois United States 61520
    48 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    49 Memorial Hospital Carthage Illinois United States 62321
    50 Hematology and Oncology Associates Chicago Illinois United States 60611
    51 Northwestern University Chicago Illinois United States 60611
    52 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    53 University of Illinois Chicago Illinois United States 60612
    54 Swedish Covenant Hospital Chicago Illinois United States 60625
    55 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    56 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    57 Eureka Hospital Eureka Illinois United States 61530
    58 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    59 Saint Francis Hospital Evanston Illinois United States 60202
    60 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    61 Ingalls Memorial Hospital Harvey Illinois United States 60426
    62 Illinois CancerCare-Havana Havana Illinois United States 62644
    63 Mason District Hospital Havana Illinois United States 62644
    64 Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois United States 60035
    65 Edward Hines Jr VA Hospital Hines Illinois United States 60141
    66 Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois United States 60521
    67 Midwest Center for Hematology Oncology Joliet Illinois United States 60432
    68 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
    69 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    70 AMITA Health Adventist Medical Center La Grange Illinois United States 60525
    71 AMG Libertyville - Oncology Libertyville Illinois United States 60048
    72 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    73 Mcdonough District Hospital Macomb Illinois United States 61455
    74 Loyola University Medical Center Maywood Illinois United States 60153
    75 Holy Family Medical Center Monmouth Illinois United States 61462
    76 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    77 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    78 Bromenn Regional Medical Center Normal Illinois United States 61761
    79 Carle Cancer Institute Normal Normal Illinois United States 61761
    80 Illinois CancerCare-Community Cancer Center Normal Illinois United States 61761
    81 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    82 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    83 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    84 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    85 Pekin Hospital Pekin Illinois United States 61554
    86 Proctor Hospital Peoria Illinois United States 61614
    87 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    88 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    89 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    90 Illinois CancerCare-Peru Peru Illinois United States 61354
    91 Illinois Valley Hospital Peru Illinois United States 61354
    92 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    93 Perry Memorial Hospital Princeton Illinois United States 61356
    94 West Suburban Medical Center River Forest Illinois United States 60305
    95 Swedish American Hospital Rockford Illinois United States 61104
    96 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61114
    97 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    98 Illinois CancerCare-Spring Valley Spring Valley Illinois United States 61362
    99 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    100 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    101 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    102 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    103 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    104 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    105 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    106 HaysMed University of Kansas Health System Hays Kansas United States 67601
    107 Hutchinson Regional Medical Center Hutchinson Kansas United States 67502
    108 University of Kansas Cancer Center-West Kansas City Kansas United States 66112
    109 University of Kansas Cancer Center Kansas City Kansas United States 66160
    110 Menorah Medical Center Overland Park Kansas United States 66209
    111 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    112 Saint Luke's South Hospital Overland Park Kansas United States 66213
    113 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
    114 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    115 Salina Regional Health Center Salina Kansas United States 67401
    116 Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    117 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    118 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    119 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    120 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    121 Saint Agnes Hospital Baltimore Maryland United States 21229
    122 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    123 Christiana Care - Union Hospital Elkton Maryland United States 21921
    124 Tufts Medical Center Boston Massachusetts United States 02111
    125 Boston Medical Center Boston Massachusetts United States 02118
    126 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    127 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    128 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    129 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    130 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    131 Ascension Saint John Hospital Detroit Michigan United States 48236
    132 Hurley Medical Center Flint Michigan United States 48503
    133 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    134 Allegiance Health Jackson Michigan United States 49201
    135 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    136 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    137 Borgess Medical Center Kalamazoo Michigan United States 49048
    138 Sparrow Hospital Lansing Michigan United States 48912
    139 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    140 UP Health System Marquette Marquette Michigan United States 49855
    141 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    142 Lake Huron Medical Center Port Huron Michigan United States 48060
    143 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    144 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    145 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    146 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    147 Mercy Hospital Coon Rapids Minnesota United States 55433
    148 Fairview Southdale Hospital Edina Minnesota United States 55435
    149 Unity Hospital Fridley Minnesota United States 55432
    150 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    151 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    152 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    153 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    154 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    155 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    156 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    157 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    158 Regions Hospital Saint Paul Minnesota United States 55101
    159 United Hospital Saint Paul Minnesota United States 55102
    160 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    161 Ridgeview Medical Center Waconia Minnesota United States 55387
    162 Rice Memorial Hospital Willmar Minnesota United States 56201
    163 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    164 University of Mississippi Medical Center Jackson Mississippi United States 39216
    165 Veterans Administration Columbia Missouri United States 65201
    166 Truman Medical Centers Kansas City Missouri United States 64108
    167 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    168 Saint Joseph Health Center Kansas City Missouri United States 64114
    169 North Kansas City Hospital Kansas City Missouri United States 64116
    170 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    171 Kansas City Veterans Affairs Medical Center Kansas City Missouri United States 64128
    172 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
    173 Research Medical Center Kansas City Missouri United States 64132
    174 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    175 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    176 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    177 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    178 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    179 Washington University School of Medicine Saint Louis Missouri United States 63110
    180 Billings Clinic Cancer Center Billings Montana United States 59101
    181 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    182 Saint Vincent Healthcare Billings Montana United States 59101
    183 Montana Cancer Consortium NCORP Billings Montana United States 59102
    184 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    185 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    186 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    187 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    188 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    189 Great Falls Clinic Great Falls Montana United States 59405
    190 Northern Montana Hospital Havre Montana United States 59501
    191 Saint Peter's Community Hospital Helena Montana United States 59601
    192 Glacier Oncology PLLC Kalispell Montana United States 59901
    193 Kalispell Medical Oncology Kalispell Montana United States 59901
    194 Kalispell Regional Medical Center Kalispell Montana United States 59901
    195 Montana Cancer Specialists Missoula Montana United States 59802
    196 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    197 Community Medical Hospital Missoula Montana United States 59804
    198 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    199 CHI Health Saint Francis Grand Island Nebraska United States 68803
    200 Great Plains Health Callahan Cancer Center North Platte Nebraska United States 69101
    201 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    202 University of Nebraska Medical Center Omaha Nebraska United States 68198
    203 Renown Regional Medical Center Reno Nevada United States 89502
    204 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    205 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    206 Virtua Memorial Mount Holly New Jersey United States 08060
    207 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    208 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    209 Virtua Voorhees Voorhees New Jersey United States 08043
    210 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    211 Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus Brooklyn New York United States 11209
    212 Maimonides Medical Center Brooklyn New York United States 11219
    213 Mount Sinai Union Square New York New York United States 10003
    214 Veterans Affairs New York Harbor Healthcare System-Manhattan Campus New York New York United States 10010
    215 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    216 Mount Sinai West New York New York United States 10019
    217 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    218 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    219 Rutherford Hospital Rutherfordton North Carolina United States 28139
    220 Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina United States 27104
    221 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    222 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    223 Case Western Reserve University Cleveland Ohio United States 44106
    224 MetroHealth Medical Center Cleveland Ohio United States 44109
    225 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    226 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    227 ProMedica Flower Hospital Sylvania Ohio United States 43560
    228 University of Toledo Toledo Ohio United States 43614
    229 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    230 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    231 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
    232 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    233 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    234 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    235 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    236 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    237 Geisinger Medical Center Danville Pennsylvania United States 17822
    238 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    239 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    240 Einstein Medical Center Philadelphia Philadelphia Pennsylvania United States 19141
    241 Roger Williams Medical Center Providence Rhode Island United States 02908
    242 AnMed Health Cancer Center Anderson South Carolina United States 29621
    243 AnMed Health Hospital Anderson South Carolina United States 29621
    244 Medical University of South Carolina Charleston South Carolina United States 29425
    245 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    246 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    247 Saint Francis Hospital Greenville South Carolina United States 29601
    248 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    249 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    250 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
    251 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    252 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    253 Dell Seton Medical Center at The University of Texas Austin Texas United States 78701
    254 University of Texas Medical Branch Galveston Texas United States 77555-0565
    255 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    256 Bon Secours Saint Francis Medical Center Midlothian Virginia United States 23114
    257 Bon Secours Saint Mary's Hospital Richmond Virginia United States 23226
    258 Hunter Holmes McGuire Veterans Administration Medical Center Richmond Virginia United States 23249
    259 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    260 MultiCare Auburn Medical Center Auburn Washington United States 98001
    261 Highline Medical Center-Main Campus Burien Washington United States 98166
    262 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    263 Providence Regional Cancer Partnership Everett Washington United States 98201
    264 Saint Francis Hospital Federal Way Washington United States 98003
    265 Saint Clare Hospital Lakewood Washington United States 98499
    266 Providence - Saint Peter Hospital Olympia Washington United States 98506-5166
    267 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    268 Virginia Mason Medical Center Seattle Washington United States 98101
    269 Kaiser Permanente Washington Seattle Washington United States 98112
    270 MultiCare Allenmore Hospital Tacoma Washington United States 98405
    271 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    272 Northwest NCI Community Oncology Research Program Tacoma Washington United States 98405
    273 Saint Joseph Medical Center Tacoma Washington United States 98405
    274 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    275 West Virginia University Healthcare Morgantown West Virginia United States 26506
    276 Princeton Community Hospital Princeton West Virginia United States 24740
    277 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    278 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    279 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    280 Rocky Mountain Oncology Casper Wyoming United States 82609
    281 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Al B Benson, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01004978
    Other Study ID Numbers:
    • NCI-2011-01981
    • NCI-2011-01981
    • ECOG-E1208
    • 10-00544
    • CDR0000657952
    • E1208
    • E1208
    • U10CA180820
    • U10CA021115
    First Posted:
    Oct 30, 2009
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Cisplatin
    Doxorubicin
    Liposomal doxorubicin
    Sorafenib
    Mitomycins
    Mitomycin

    Study Results

    No Results Posted as of Jul 28, 2022