Sorafenib in Elderly mRCC

Bayer

Status: Completed

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01728948

16399

NX1212CN (Other Identifier)

Details and patient eligibility

About

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%.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria

Trial design

60 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)