Clinical trial NCT00812175: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
Official title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Carcinoma
HCC
Sorafenib
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 3371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at each follow-up visit, every 2-4 months on average
Secondary outcomes:
measure: 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
timeFrame: at every visit, roughly every 2-4 months
measure: The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables
timeFrame: at every visit, roughly every 2-4 months
measure: To evaluate the methods of patient evaluation, diagnosis and follow up
timeFrame: at every visit, roughly every 2-4 months
measure: To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome
timeFrame: at every visit, roughly every 2-4 months
measure: To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions
timeFrame: at every visit, roughly every 2-4 months
measure: Reports of adverse events
timeFrame: at every visit, roughly every 2-4 months
Other outcomes:
Locations:
city: Many Locations
country: United States
state: Alabama
city: Many Locations
country: United States
state: Arizona
city: Many Locations
country: United States
state: Arkansas
city: Many Locations
country: United States
state: California
city: Many Locations
country: United States
state: Colorado
city: Many Locations
country: United States
state: Connecticut
city: Many Locations
country: United States
state: Florida
city: Many Locations
country: United States
state: Georgia
city: Many Locations
country: United States
state: Hawaii
city: Many Locations
country: United States
state: Illinois
city: Many Locations
country: United States
state: Indiana
city: Many Locations
country: United States
state: Iowa
city: Many Locations
country: United States
state: Kansas
city: Many Locations
country: United States
state: Kentucky
city: Many Locations
country: United States
state: Louisiana
city: Many Locations
country: United States
state: Maryland
city: Many Locations
country: United States
state: Massachusetts
city: Many Locations
country: United States
state: Michigan
city: Many Locations
country: United States
state: Minnesota
city: Many Locations
country: United States
state: Missouri
city: Many Locations
country: United States
state: Nebraska
city: Many Locations
country: United States
state: Nevada
city: Many Locations
country: United States
state: New Hampshire
city: Many Locations
country: United States
state: New Jersey
city: Many Locations
country: United States
state: New York
city: Many Locations
country: United States
state: North Carolina
city: Many Locations
country: United States
state: Ohio
city: Many Locations
country: United States
state: Oklahoma
city: Many Locations
country: United States
state: Oregon
city: Many Locations
country: United States
state: Pennsylvania
city: Many Locations
country: United States
state: South Carolina
city: Many Locations
country: United States
state: Tennessee
city: Many Locations
country: United States
state: Texas
city: Many Locations
country: United States
state: Utah
city: Many Locations
country: United States
state: Virginia
city: Many Locations
country: United States
state: Washington
city: Many Locations
country: United States
state: Wisconsin
city: Many Locations
country: Canada
city: Many Locations
country: China
city: Many Locations
country: Colombia
city: Many Locations
country: Croatia
city: Many Locations
country: Czech Republic
city: Many Locations
country: Finland
city: Many Locations
country: France
city: Many Locations
country: Greece
city: Many Locations
country: Hong Kong
city: Many Locations
country: Hungary
city: Many Locations
country: India
city: Many Locations
country: Indonesia
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Japan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Libyan Arab Jamahiriya
city: Many Locations
country: Malaysia
city: Many Locations
country: Mexico
city: Many Locations
country: Norway
city: Many Locations
country: Pakistan
city: Many Locations
country: Philippines
city: Many Locations
country: Portugal
city: Many Locations
country: Qatar
city: Many Locations
country: Romania
city: Many Locations
country: Russian Federation
city: Many Locations
country: Singapore
city: Many Locations
country: Slovakia
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Syrian Arab Republic
city: Many Locations
country: Thailand
city: Many Locations
country: Ukraine
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: Uruguay
city: Many Locations
country: Venezuela
city: Many Locations
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.