Clinical trial NCT01191385: GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start
Official title: Non Interventional Study in Patients With Diagnosis of HCC in Whom a Decision to Treat With Sorafenib Has Not Been Made at Time of Study Enrollment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
Liver cancer
Cancer of liver
Cancer, liver
Hepatic cancer
Cancer, hepatic
Carcinoma, hepatocellular
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2010-08-30
Enrollment: 0
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 in whom a decision to treat with sorafenib has not been made at time of study enrollment and who were never treated with sorafenib in the past

Brief summary: This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Outpatients with histologically/cytologically documented or radiographically diagnosed HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis 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:

* Patients in whom a decision to treat with sorafenib is made at time of study start
* Patients who have received sorafenib in the past or are currently treated with sorafenib
* Hospice patients

Primary outcomes:
measure: Determination of 'real-life' practice patterns of physicians involved in the care of patients with HCC (collection of data on treatments prescribed as well as demographic data and data on the entire medical history)
timeFrame: up to 3,3 years
measure: Evaluation of patient demographics, disease characteristics, methods of patient evaluation, diagnosis and follow-up of patients with HCC, regionally and globally (collection of data on demographics, medical history, diagnostic measurements, follow-up)
timeFrame: up to 3,3 years
Secondary outcomes:
measure: Evaluation of natural course and outcomes of patients with HCC (collection of data of disease status during the course of the study and the outcome of treatment)
timeFrame: up to 3,3 years
measure: Evaluation of treatment modalities that are used for patients with HCC during the course of their disease (collection of data of all treatments prescribed during the course of the study)
timeFrame: up to 3,3 years
measure: Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)
timeFrame: up to 3,3 years
measure: Evaluation efficacy parameters including: overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR) and stable disease (SD) rate of the various interventions employed in the care of patients with HCC
timeFrame: up to 3,3 years
measure: To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)
timeFrame: up to 3,3 years
Other outcomes:
Locations:
city: Multiple Locations
country: United States
state: Arkansas
city: Multiple Locations
country: United States
state: California
city: Multiple Locations
country: United States
state: Colorado
city: Multiple Locations
country: United States
state: District of Columbia
city: Multiple Locations
country: United States
state: Florida
city: Multiple Locations
country: United States
state: Georgia
city: Multiple Locations
country: United States
state: Illinois
city: Multiple Locations
country: United States
state: Indiana
city: Multiple Locations
country: United States
state: Iowa
city: Multiple Locations
country: United States
state: Kentucky
city: Multiple Locations
country: United States
state: Louisiana
city: Multiple Locations
country: United States
state: Maryland
city: Multiple Locations
country: United States
state: Massachusetts
city: Multiple Locations
country: United States
state: Michigan
city: Multiple Locations
country: United States
state: Minnesota
city: Multiple Locations
country: United States
state: Missouri
city: Multiple Locations
country: United States
state: New Hampshire
city: Multiple Locations
country: United States
state: New Jersey
city: Multiple Locations
country: United States
state: New York
city: Multiple Locations
country: United States
state: Oregon
city: Multiple Locations
country: United States
state: Pennsylvania
city: Multiple Locations
country: United States
state: South Carolina
city: Multiple Locations
country: United States
state: Texas
city: Multiple Locations
country: United States
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: