stop_circleTerminated/Withdrawn
Carcinoma, Hepatocellular
Bayer Identifier:
14611
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
GIDEON Non-Nexavar Arm - HCC patients who are treated with any therapy other than Nexavar at individual study start
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
0Trial Dates
November 2010 - December 2013Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States | |
Terminated | Many Locations, United States |
Primary Outcome
- 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)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- 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)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
- Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionYesSafety Issue:
- 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 HCCdate_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
- To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)date_rangeTime Frame:up to 3,3 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A