check_circleStudy Completed
Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)
Bayer Identifier:
14686
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Patient characteristics in advanced renal cell carcinoma and daily practice treatment with Nexavar
Trial purpose
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
2840Trial Dates
July 2006 - August 2010Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, France | |
Completed | Many Locations, Netherlands | |
Completed | Many Locations, Argentina | |
Completed | Many Locations, Greece | |
Completed | Many Locations, Slovakia | |
Completed | Many Locations, Korea, Republic Of | |
Completed | Many Locations, Philippines | |
Completed | Many Locations, Germany | |
Completed | Many Locations, Poland | |
Completed | Many Locations, Mexico | |
Completed | Many Locations, Sweden | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Austria | |
Completed | Many Locations, Colombia | |
Completed | Many Locations, Russia | |
Completed | Many Locations, China | |
Completed | Many Locations, Indonesia | |
Completed | Many Locations, Slovenia |
Primary Outcome
- Tumor statusdate_rangeTime Frame:After about 3, 6, 9 and 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Treatment durationdate_rangeTime Frame:At end of study after about 12 monthsenhanced_encryptionNoSafety Issue:
- Safety of sorafenib treatmentdate_rangeTime Frame:At every documented visit for about 12 monthsenhanced_encryptionYesSafety Issue:
- Progression-free survivaldate_rangeTime Frame:Calculation at end of study after about 12 monthsenhanced_encryptionNoSafety Issue:
- Status of Metastasesdate_rangeTime Frame:After about 3, 6, 9 and 12 monthsenhanced_encryptionNoSafety Issue:
- Performance status (ECOG)date_rangeTime Frame:After about 3, 6, 9 and 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A