Renal cell carcinoma
Conditions
Interventions
Sorafenib will be given by daily oral administration of 400 mg twice a day
Sponsors
Kobe University Graduate school of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: At least 20 years of age 2) Patients with ECOG PS 0 or 1 3) Patients who have only lung metastases and confirmed including clear cell renal cell carcinoma 4) Patients who have already nephrectomy 5) Patients with no previous history of cytokine therapy, chemotherapy, or molecularly targeted drug therapy 6) Patients who are expected to survive at least 12 weeks
Exclusion criteria
Exclusion criteria: 1) Patients who have or have had thromboembolism and/or ischemic cardiac disease 2) Poorly controlled hypertension 3) Patients with serious hepatic function disorder 4) Patients who have or have had interstitial pulmonary disease 5) Pregnant or nursing patients 6) Patients being treated with other drugs for purpose of anti cancer treatment 7) Patients who may otherwise compromise subject safety in the conduct of the trial or who may compromise protocol compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate(CR+PR+SD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate(CR+PR),Progression Free Survival(PFS),Safety | — |
Countries
Japan
Contacts
Public ContactHideaki Miyake
Kobe University Graduate school of Medicine Department of Urology
Outcome results
None listed