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Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib (GIDEON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00812175
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):

Brief Summary:
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type : Observational
Actual Enrollment : 3371 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
Study Start Date : January 2009
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information

Primary Outcome Measures :
  1. The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions [ Time Frame: at each follow-up visit, every 2-4 months on average ]

Secondary Outcome Measures :
  1. Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar [ Time Frame: at every visit, roughly every 2-4 months ]
  2. The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables [ Time Frame: at every visit, roughly every 2-4 months ]
  3. To evaluate the methods of patient evaluation, diagnosis and follow up [ Time Frame: at every visit, roughly every 2-4 months ]
  4. To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome [ Time Frame: at every visit, roughly every 2-4 months ]
  5. To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions [ Time Frame: at every visit, roughly every 2-4 months ]
  6. Reports of adverse events [ Time Frame: at every visit, roughly every 2-4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions and in a variety of patient subsets.

Inclusion Criteria:

  • Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
  • Patients must have signed an informed consent form
  • Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

  • Exclusion criteria must follow the approved local product information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812175

  Hide Study Locations
United States, Alabama
Many Locations, Alabama, United States
United States, Arizona
Many Locations, Arizona, United States
United States, Arkansas
Many Locations, Arkansas, United States
United States, California
Many Locations, California, United States
United States, Colorado
Many Locations, Colorado, United States
United States, Connecticut
Many Locations, Connecticut, United States
United States, Florida
Many Locations, Florida, United States
United States, Georgia
Many Locations, Georgia, United States
United States, Hawaii
Many Locations, Hawaii, United States
United States, Illinois
Many Locations, Illinois, United States
United States, Indiana
Many Locations, Indiana, United States
United States, Iowa
Many Locations, Iowa, United States
United States, Kansas
Many Locations, Kansas, United States
United States, Kentucky
Many Locations, Kentucky, United States
United States, Louisiana
Many Locations, Louisiana, United States
United States, Maryland
Many Locations, Maryland, United States
United States, Massachusetts
Many Locations, Massachusetts, United States
United States, Michigan
Many Locations, Michigan, United States
United States, Minnesota
Many Locations, Minnesota, United States
United States, Missouri
Many Locations, Missouri, United States
United States, Nebraska
Many Locations, Nebraska, United States
United States, Nevada
Many Locations, Nevada, United States
United States, New Hampshire
Many Locations, New Hampshire, United States
United States, New Jersey
Many Locations, New Jersey, United States
United States, New York
Many Locations, New York, United States
United States, North Carolina
Many Locations, North Carolina, United States
United States, Ohio
Many Locations, Ohio, United States
United States, Oklahoma
Many Locations, Oklahoma, United States
United States, Oregon
Many Locations, Oregon, United States
United States, Pennsylvania
Many Locations, Pennsylvania, United States
United States, South Carolina
Many Locations, South Carolina, United States
United States, Tennessee
Many Locations, Tennessee, United States
United States, Texas
Many Locations, Texas, United States
United States, Utah
Many Locations, Utah, United States
United States, Virginia
Many Locations, Virginia, United States
United States, Washington
Many Locations, Washington, United States
United States, Wisconsin
Many Locations, Wisconsin, United States
Many Locations, Canada
Many Locations, China
Many Locations, Colombia
Many Locations, Croatia
Czech Republic
Many Locations, Czech Republic
Many Locations, Finland
Many Locations, France
Many Locations, Greece
Hong Kong
Many Locations, Hong Kong
Many Locations, Hungary
Many Locations, India
Many Locations, Indonesia
Many Locations, Israel
Many Locations, Italy
Many Locations, Japan
Many Locations, Kazakhstan
Korea, Republic of
Many Locations, Korea, Republic of
Libyan Arab Jamahiriya
Many Locations, Libyan Arab Jamahiriya
Many Locations, Malaysia
Many Locations, Mexico
Many Locations, Norway
Many Locations, Pakistan
Many Locations, Philippines
Many Locations, Portugal
Many Locations, Qatar
Many Locations, Romania
Russian Federation
Many Locations, Russian Federation
Many Locations, Singapore
Many Locations, Slovakia
Many Locations, Spain
Many Locations, Sweden
Syrian Arab Republic
Many Locations, Syrian Arab Republic
Many Locations, Thailand
Many Locations, Ukraine
United Arab Emirates
Many Locations, United Arab Emirates
Many Locations, Uruguay
Many Locations, Venezuela
Many Locations, Vietnam
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00812175     History of Changes
Other Study ID Numbers: 13414
NX0802 ( Other Identifier: company internal )
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016

Keywords provided by Bayer:
Hepatocellular Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs