a study on Kidney Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
OUTLINE: This is a multicenter study.
Patients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
Archived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.
Kidney Cancer stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer clear cell renal cell carcinoma papillary renal cell carcinoma Everolimus Sirolimus
For people ages 18 years to 120 years
PRIOR CONCURRENT THERAPY:
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