A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

Inclusion Criteria

• High risk renal cancer per modified UISS criteria
• Eastern Cooperative Oncology Group (ECOG) 0-2
• predominant clear cell histology
• No prior anti-cancer treatment
• Kidney tumor has been removed
• No evidence of macroscopic disease following surgery

Exclusion Criteria

• Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
• Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
• known HIV or Hepatitis
• any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration