Carcinoma, Renal Cell
Conditions
Keywords
Sorafenib, renal cell carcinoma(RCC), elderly, effectiveness, safety
Brief summary
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment. * \>=65 years of age * Patients who have signed the informed consent * Patients with a life expectancy of ≥12 weeks * No prior systemic treatment
Exclusion criteria
* The approved local product label must be followed for the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | up to 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria | up to 2.5 years |
| Survival rate by one year | up to 1 year |
| Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability | up to 3.5 years |
| Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria | up to 2.5 years |
| Response rate (RR) | up to 3.5 years |
| Time to first relief of clinical symptoms and physical signs | up to 3.5 years |
| Treatment pattern | up to 3.5 years |
| Patient characteristics (birthdate (at least year), sex, weight, height, etc) | up to 2.5 years |
Countries
China
Outcome results
None listed