GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start

N/AWithdrawnNCT01191385

Bayer

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Carcinoma, Hepatocellular

Interventions

Any treatment for unresectable HCC as chosen by the physicianDRUG

Only those patient are allowed to be enrolled that receive any HCC treatment for unresectable HCC as chosen by the physician except sorafenib. During the course of the study, each treatment is allowed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Unnamed facility

Multiple Locations, Arkansas, United States

Unnamed facility

Multiple Locations, California, United States

Outcomes

Primary Outcomes

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)

Time frame: up to 3,3 years

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)

Time frame: up to 3,3 years

Secondary Outcomes

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)

Time frame: up to 3,3 years

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)

Time frame: up to 3,3 years

Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)

Time frame: up to 3,3 years

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

Time frame: up to 3,3 years

To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)

Time frame: up to 3,3 years

Data from ClinicalTrials.gov

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