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

NCT01191385 | Withdrawn

• 2 other identifiers: 14611NX0901
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 24

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.

Conditions

Carcinoma, Hepatocellular

Keywords

HCC; Liver cancer; Cancer of liver; Cancer, liver; Hepatic cancer; Cancer, hepatic; Carcinoma, hepatocellular

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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

• 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

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

  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

  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)

  up to 3,3 years

Study Arms (1)

Group 1

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

Interventions

Any treatment for unresectable HCC as chosen by the physician DRUG

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Amgen: collaborator

Study Sites (24)

Unknown Facility

Multiple Locations, Arkansas, United States

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Unknown Facility

Multiple Locations, California, United States

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Unknown Facility

Multiple Locations, Colorado, United States

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Unknown Facility

Multiple Locations, District of Columbia, United States

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Unknown Facility

Multiple Locations, Florida, United States

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Unknown Facility

Multiple Locations, Georgia, United States

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Unknown Facility

Multiple Locations, Illinois, United States

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Unknown Facility

Multiple Locations, Indiana, United States

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Unknown Facility

Multiple Locations, Iowa, United States

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Unknown Facility

Multiple Locations, Kentucky, United States

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Unknown Facility

Multiple Locations, Louisiana, United States

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Unknown Facility

Multiple Locations, Maryland, United States

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Unknown Facility

Multiple Locations, Massachusetts, United States

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Unknown Facility

Multiple Locations, Michigan, United States

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Unknown Facility

Multiple Locations, Minnesota, United States

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Unknown Facility

Multiple Locations, Missouri, United States

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Unknown Facility

Multiple Locations, New Hampshire, United States

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Unknown Facility

Multiple Locations, New Jersey, United States

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Unknown Facility

Multiple Locations, New York, United States

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Unknown Facility

Multiple Locations, Oregon, United States

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Unknown Facility

Multiple Locations, Pennsylvania, United States

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Unknown Facility

Multiple Locations, South Carolina, United States

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Unknown Facility

Multiple Locations, Texas, United States

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Unknown Facility

Multiple Locations, Virginia, United States

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 16, 2017

Record last verified: 2015-03

Locations

US (24)