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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00812175
First received: December 19, 2008
Last updated: July 11, 2012
Last verified: July 2012
History of Changes

December 19, 2008
July 11, 2012
January 2009
Not Provided
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00812175 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the methods of patient evaluation, diagnosis and follow up [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reports of adverse events [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the methods of patient evaluation, diagnosis and follow up [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reports of adverse events [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3721
April 2012
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   China,   Colombia,   Croatia,   Czech Republic,   Finland,   France,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   Italy,   Japan,   Kazakhstan,   Korea, Republic of,   Libyan Arab Jamahiriya,   Malaysia,   Mexico,   Norway,   Pakistan,   Philippines,   Portugal,   Qatar,   Romania,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   Spain,   Sweden,   Syrian Arab Republic,   Thailand,   Ukraine,   United Arab Emirates,   Uruguay,   Venezuela,   Vietnam
 
NCT00812175
13414, NX0802
No
Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP