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OpenTrials
Completed

NCT Number: NCT00812175

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Systemic oral therapy according to product information

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: GIDEON

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2008
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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