Clinical Trial ECOGUROS0931
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
- Protocol No. ECOGUROS0931
- Open Date: 03/12/2013
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.
- Disease Sites: Kidney (Renal Cell)
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Everolimus (RAD001)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: 01120249
- Secondary Protocol No: S0931
The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named mTOR. Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, participants will get either everolimus or placebo (a pill with no medication).