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

This study has been withdrawn prior to enrollment.
(Study is officially cancelled bevore FPFV.)
Information provided by:
Bayer Identifier:
First received: August 27, 2010
Last updated: March 17, 2015
Last verified: March 2015
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.

Condition Intervention
Carcinoma, Hepatocellular
Drug: Any treatment for unresectable HCC as chosen by the physician

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01191385

  Show 24 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG Identifier: NCT01191385     History of Changes
Other Study ID Numbers: 14611
Study First Received: August 27, 2010
Last Updated: March 17, 2015

Keywords provided by Bayer:
Liver cancer
Cancer of liver
Cancer, liver
Hepatic cancer
Cancer, hepatic
Carcinoma, hepatocellular

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 26, 2017