ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

IRB-HSR# 13763
Service: Cancer | Category: Cancer (Oncology)
Adult Enrollment: No | Minor Enrollment: No
Primary Investigator: Christopher Thomas, M.D.

Contact Information

Contact: Elaine Dube
Phone: 434.924.9199
E-mail: ed7y@virginia.edu

Clinical Trial Description

UVA Health System, Department of Medicine, Hematology/Oncology seeks Men and Women ages 18 and older with kidney cancer that has been removed or is about to be removed and is thought to be a high risk for recurrence for a research study.

The purpose of the study is to determine if Sunitinib or Sorafenib can prevent recurrence of kidney cancer and to compare the effects of Sunitinib and Sorafenib on kidney cancer. This study involves taking an experimental medicine, blood draws, urine test, check of blood pressure, CT and/or MRI scans, MUGA scan or Echocardiogram, EKG and a pregnancy test if you are female of childbearing potential. Treatment consists of taking oral medication daily for 6 weeks over 9 cycles. Visits will occur every 6 weeks prior the beginning of each new cycle. The entire treatment period will last 54 weeks and your medical condition is followed for 10 years after.

Study-related medication provided free of charge. However if these drugs become commercially available for this indication, there is a remote possibility that you maybe asked to purchase subsequent supplies.

Participant's insurance company will be billed for tests and procedures.

Compensation

No compensation is provided for this study.