The Eastern Oncology Cooperative Group (ECOG) is
sponsoring this study because there is no
effective therapy to prevent recurrence of kidney
cancer. The purpose of this study is to determine
if either Sunitinib or Sorafenib can prevent
recurrence of your kidney cancer and to compare
the effects (both good and bad) of the Sunitinib
and the Sorafenib with Placebo (inactive agent) on
you and your kidney cancer to see which is better.
18 yrs or older.
Renal Cell Carcinoma with surgery planned, or post
surgery - must have tumor fully removed during
surgery.
Tumor size must be 4cm or larger.
No prior anti-cancer treatment.
No history of distant metastasis,
Can no be breastfeeding or pregnant, and must
agree to use adequate birth control (males and
females) prior to and during study participation.
If you agree to take part in this study, you will
take 2 tablets of Sorafenib or Placebo twice a day
for 6 weeks and 4 capsules of Sunitinib or Placebo
once a day for 4 weeks followed by a 2 week break.
This regimen is called a cycle. You will follow 9
cycles of this treatment for approximately one
year.. During this time you will undergo routine
physical exams, blood tests, CT scans, heart
scans, and bone scans to make sure you are
tolerating the study medication and to make sure
your kidney cancer has not returned. After you
have completed one year of therapy, you will stop
taking the study medications but will continue to
be followed for possible side effects from the
therapy and to detect possible recurrence of your
cancer. You will continue to be followed for 10 years.
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