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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01191385
• Other study ID #: 14611
• Secondary ID: NX0901
• Status: Withdrawn
• Phase: N/A
• First received: August 27, 2010
• Last updated: August 14, 2017
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Drug:
• Any treatment for unresectable HCC as chosen by the physician
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		up to 3,3 years
Primary	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)		up to 3,3 years
Secondary	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)		up to 3,3 years
Secondary	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)		up to 3,3 years
Secondary	Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)		up to 3,3 years
Secondary	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		up to 3,3 years
Secondary	To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)		up to 3,3 years

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