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

NCT00812175 | Completed

• 2 other identifiers: 13414NX0802
• Study Type: observational
• Target: 3,371
• Locations: 39 countries
• Sites: 75

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma; HCC; Sorafenib

Outcome Measures

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

  at each follow-up visit, every 2-4 months on average

Secondary Outcomes (6)

• 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

  at every visit, roughly every 2-4 months

• The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables

  at every visit, roughly every 2-4 months

• To evaluate the methods of patient evaluation, diagnosis and follow up

  at every visit, roughly every 2-4 months

• To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome

  at every visit, roughly every 2-4 months

• To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions

  at every visit, roughly every 2-4 months

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Systemic oral therapy according to product information

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (75)

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Many Locations, Alabama, United States

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Many Locations, Arizona, United States

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Many Locations, Arkansas, United States

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Many Locations, California, United States

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Many Locations, Colorado, United States

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Many Locations, Connecticut, United States

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Many Locations, Florida, United States

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Many Locations, Georgia, United States

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Many Locations, Hawaii, United States

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Many Locations, Illinois, United States

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Many Locations, Indiana, United States

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Many Locations, Iowa, United States

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Many Locations, Kansas, United States

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Many Locations, Kentucky, United States

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Many Locations, Louisiana, United States

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Many Locations, Maryland, United States

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Many Locations, Massachusetts, United States

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Many Locations, Michigan, United States

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Many Locations, Minnesota, United States

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Many Locations, Missouri, United States

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Many Locations, Nebraska, United States

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Many Locations, Nevada, United States

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Many Locations, New Hampshire, United States

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Many Locations, New Jersey, United States

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Many Locations, New York, United States

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Many Locations, North Carolina, United States

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Many Locations, Ohio, United States

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Many Locations, Oklahoma, United States

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Many Locations, Oregon, United States

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Many Locations, Pennsylvania, United States

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Many Locations, South Carolina, United States

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Many Locations, Tennessee, United States

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Many Locations, Texas, United States

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Many Locations, Utah, United States

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Many Locations, Virginia, United States

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Many Locations, Washington, United States

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Many Locations, Wisconsin, United States

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Many Locations, Canada

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Many Locations, China

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Many Locations, Colombia

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Many Locations, Croatia

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Many Locations, Czechia

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Many Locations, Finland

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Many Locations, France

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Many Locations, Greece

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Many Locations, Hong Kong

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Many Locations, Hungary

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Many Locations, India

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Many Locations, Indonesia

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Many Locations, Israel

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Many Locations, Italy

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Many Locations, Japan

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Many Locations, Kazakhstan

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Many Locations, Libya

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Many Locations, Malaysia

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Many Locations, Mexico

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Many Locations, Norway

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Many Locations, Pakistan

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Many Locations, Philippines

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Many Locations, Portugal

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Many Locations, Qatar

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Many Locations, Romania

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Many Locations, Russia

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Many Locations, Singapore

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Many Locations, Slovakia

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Many Locations, South Korea

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Many Locations, Spain

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Many Locations, Sweden

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Many Locations, Syria

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Many Locations, Thailand

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Many Locations, Ukraine

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Many Locations, United Arab Emirates

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Many Locations, Uruguay

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Many Locations, Venezuela

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Many Locations, Vietnam

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Related Publications (4)

• Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781.

  PMID: 26735891 RESULT

• Ye SL, Yang J, Bie P, Zhang S, Chen X, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Lv Z. Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study. BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9.

  PMID: 29499662 DERIVED

• Kudo M, Lencioni R, Marrero JA, Venook AP, Bronowicki JP, Chen XP, Dagher L, Furuse J, Geschwind JF, Ladron de Guevara L, Papandreou C, Sanyal AJ, Takayama T, Yoon SK, Nakajima K, Lehr R, Heldner S, Ye SL. Regional differences in sorafenib-treated patients with hepatocellular carcinoma: GIDEON observational study. Liver Int. 2016 Aug;36(8):1196-205. doi: 10.1111/liv.13096. Epub 2016 Apr 1.

  PMID: 26901163 DERIVED

• 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. doi: 10.1111/j.1742-1241.2010.02414.x.

  PMID: 20642705 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

PT (1); HU (1); QA (1); GR (1); UA (1); ES (1); ID (1); SL (1); FI (1); IT (1); CN (1); JP (1); KR (1); UR (1); KA (1); RU (1); ME (1); VE (1); PH (1); US (37); AE (1); MY (1); PA (1); TH (1); SE (1); CR (1); VN (1); RO (1); CA (1); SG (1); SY (1); FR (1); CO (1); HK (1); IL (1); LI (1); NO (1); CZ (1); IN (1)