AzTrials
AzTrials

Hepatocellular CarcinomaPhase 3NCT01004978

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

A Phase 3 study testing Cisplatin, Computed Tomography and Doxorubicin Hydrochloride in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 281 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Computed Tomography and Doxorubicin Hydrochloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
281 sitesUnited States
Study dates
28 Oct 2009to 21 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

281 sites in 1 country.

281 sites in 1 country

United States281 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus

    Brooklyn, New York, 11209

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Veterans Administration

    Columbia, Missouri, 65201

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hutchinson Regional Medical Center

    Hutchinson, Kansas, 67502

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • University of Kansas Cancer Center-West

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • The University of Kansas Cancer Center-South

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • John L McClellan Memorial Veterans Hospital

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • UP Health System Marquette

    Marquette, Michigan, 49855

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Yale University

    New Haven, Connecticut, 06520

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Mount Sinai Union Square

    New York, New York, 10003

  • Veterans Affairs New York Harbor Healthcare System-Manhattan Campus

    New York, New York, 10010

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai West

    New York, New York, 10019

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Great Plains Health Callahan Cancer Center

    North Platte, Nebraska, 69101

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania, 19141

  • Ascension Via Christi - Pittsburg

    Pittsburg, Kansas, 66762

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Princeton Community Hospital

    Princeton, West Virginia, 24740

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

  • Hunter Holmes McGuire Veterans Administration Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • West Suburban Medical Center

    River Forest, Illinois, 60305

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Swedish American Hospital

    Rockford, Illinois, 61104

  • SwedishAmerican Regional Cancer Center/ACT

    Rockford, Illinois, 61114

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Advent Health - Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Hematology Oncology Associates of Illinois - Skokie

    Skokie, Illinois, 60076

  • Ascension Providence Hospitals - Southfield

    Southfield, Michigan, 48075

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Illinois CancerCare-Spring Valley

    Spring Valley, Illinois, 61362

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Northwest NCI Community Oncology Research Program

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • University of Toledo

    Toledo, Ohio, 43614

  • Mercy Health - Saint Anne Hospital

    Toledo, Ohio, 43623

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Veterans Affairs Medical Center -Washington DC

    Washington D.C., District of Columbia, 20422

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Southeast Clinical Oncology Research Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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. Kinase inhibitors, such as sorafenib tosylate may stop the growth of tumor cells by blocking the action of an abnormal protein that signals cancer cells to multiply. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.

Read the 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.

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:

  1. 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.

  1. 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.

Being tested
Cisplatin, Computed Tomography, Doxorubicin Hydrochloride, Doxorubicin-Eluting Beads, Laboratory Biomarker Analysis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Undergo TACE

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Doxorubicin HydrochlorideDrug

    Also called 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

    Undergo TACE

  • Doxorubicin-Eluting BeadsDrug

    Undergo TACE

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • MitomycinDrug

    Also called Ametycine, Jelmyto, MITO, Mito-C

    Undergo TACE

  • Pharmacological StudyOther

    Correlative studies

  • Placebo AdministrationOther

    Given PO

  • Sorafenib TosylateDrug

    Also called BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

    Given PO

Study groups in NCT01004978
Study groupRoleWhat they receive
Arm I (sorafenib tosylate and TACE)ExperimentalPatients 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.
Receives: Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Drug: Doxorubicin-Eluting Beads; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Drug: Mitomycin; Other: Pharmacological Study; Drug: Sorafenib Tosylate
Arm II (placebo and TACE)Active comparatorPatients 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.
Receives: Drug: Cisplatin; Procedure: Computed Tomography; Drug: Doxorubicin Hydrochloride; Drug: Doxorubicin-Eluting Beads; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Drug: Mitomycin; Other: Pharmacological Study; Other: Placebo Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS is defined to be the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up will be censored at the date of last disease assessment without progression, unless death occurs within 4 months following the date last known progression-free, in which case the death will be counted as an event.

    Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.

    Measured: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

Secondary outcomes (3)

  1. Overall Survival (OS)

    Overall survival (OS) is defined as time from randomization to death from any cause, censoring cases who had not died at the date last known alive.

    Measured: Assessed every 3 months for 2 years and then every 6 months for 2 years

  2. Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression

    PFS is defined to be the time from randomization to progression or death without evidence of progression.

    Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.

    For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. Patients with both intra- and extra-hepatic progression were considered as having extra-hepatic progression. This analysis was performed among patients with extra-hepatic progression.

    Measured: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

  3. Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression

    PFS is defined to be the time from randomization to progression or death without evidence of progression.

    Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.

    For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. This analysis was performed among patients with intra-hepatic progression.

    Measured: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2009 (estimated)
  2. Study start28 Oct 2009
  3. Primary completion11 Feb 2021
  4. Study completion21 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004978
Sponsor's protocol ID
NCI-2011-01981
Other IDs
NCI-2011-01981, ECOG-E1208, 10-00544, CDR0000657952, E1208, E1208, U10CA021115, U10CA180820
Status last verified
Nov 2023
First submitted
29 Oct 2009
Last updated
3 Jan 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Computed Tomography and Doxorubicin Hydrochloride in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 281 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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