Sunitinib Treatment Of Renal Adjuvant Cancer (S-TRAC): A Randomized Double Blind Phase 3 Study Of Adjuvant Sunitinib VS. Placebo In Subjects At High Risk Of Recurrent RCC

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