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Clinical Trial Name - Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment Wit
| Original Study ID : 13414 |
| Secondary ID : NX0802 |
| NCT ID : NCT00812175 |
| Brief Title : Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib |
| Official Title : Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib |
| Brief Summary : In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from HCC will be collected. |
| Source : Bayer |
| Overall Status : Recruiting |
| Start Date : January 2009 |
| End Date : December 2013 |
| Completion Date : December 2013 |
| Official Title : N/A |
| Phase : Observational |
| Study Design : Cohort, Prospective |
| Enrollment : 3000 |
| Verification Date : May 2009 |
| First Received Date : December 19, 2008 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, 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: - Exclusion criteria must follow the approved local product information |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Status : Recruiting |
| City : Many Locations |
| State : Alabama |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Arizona |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Arkansas |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : California |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Colorado |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Connecticut |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Florida |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Georgia |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Hawaii |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Illinois |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Iowa |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Kansas |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Kentucky |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Louisiana |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Maryland |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Massachusetts |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Michigan |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Minnesota |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Missouri |
| Country : United States |
| Status : Recruiting |
| City : Manc Locations |
| State : Nebraska |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Nevada |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : New Hampshire |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : New Jersey |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : New York |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : North Carolina |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Ohio |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Oklahoma |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Oregon |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Pennsylvania |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : South Carolina |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Tennessee |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Texas |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Utah |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Virginia |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Washington |
| Country : United States |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : United States |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Bahrain |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Belgium |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Bosnia and Herzegovina |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : China |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Colombia |
| Status : Not yet recruiting |
| City : Manc Locations |
| State : Wisconsin |
| Country : Croatia |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Czech Republic |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Denmark |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Egypt |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : France |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Greece |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Hong Kong |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Hungary |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : India |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Indonesia |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Israel |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Italy |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Japan |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Jordan |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Korea, Republic of |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Kuwait |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Libyan Arab Jamahiriya |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Malaysia |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Mexico |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Morocco |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Norway |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Oman |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Philippines |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Poland |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Portugal |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Qatar |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Romania |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Russian Federation |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Saudi Arabia |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Singapore |
| Status : Not yet recruiting |
| City : Manc Locations |
| State : Wisconsin |
| Country : Slovakia |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Slovenia |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : South Africa |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Spain |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Sweden |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Syrian Arab Republic |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Taiwan |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Turkey |
| Status : Suspended |
| City : Many Locations |
| State : Wisconsin |
| Country : Ukraine |
| Status : Not yet recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : United Arab Emirates |
| Status : Recruiting |
| City : Many Locations |
| State : Wisconsin |
| Country : Venezuela |
| OutComes |
| Primary OutComes |
| Measure : The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions |
| Time Frame : at each follow-up visit, every 2-4 months on average |
| Safety issue : Yes |
| Secondary OutComes |
| Measure : Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : No |
| Measure : The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : No |
| Measure : To evaluate the methods of patient evaluation, diagnosis and follow up |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : No |
| Measure : To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : No |
| Measure : To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : No |
| Measure : Reports of adverse events |
| Time Frame : at every visit, roughly every 2-4 months |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : Sorafenib (Nexavar, BAY43-9006) |
| Description : Systemic oral therapy according to product information |
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