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%.
Study Type
OBSERVATIONAL
Enrollment
60
treatment (including dose, duration, modification) decided by the investigator
Unnamed facility
Many Locations, China
Overall survival
Time frame: up to 2.5 years
Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Time frame: up to 2.5 years
Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
Time frame: up to 2.5 years
Survival rate by one year
Time frame: up to 1 year
Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
Time frame: up to 3.5 years
Patient characteristics (birthdate (at least year), sex, weight, height, etc)
Time frame: up to 2.5 years
Response rate (RR)
Time frame: up to 3.5 years
Time to first relief of clinical symptoms and physical signs
Time frame: up to 3.5 years
Treatment pattern
Time frame: up to 3.5 years
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