|
ECOG 2805 (ASSURE)
Adjuvant Sunitinib or Sorafenib for Unfavorable Renal Carcinoma
Principal Investigator:
James F. Strauss, M.D.
Co-Investigators:
Minal Barve, M.D.
Jaya V. Juturi, M.D.
Kiran R. Kancharla, M.D.
Haskell Kirkpatrick, M.D.
Kristi J. McIntyre, M.D.
Gabriel A. Shapiro, M.D.
Chiyu Wang, M.D.
Lalan S. Wilfong, M.D.
Purpose:
There is no known effective therapy to prevent recurrence of kidney cancer after surgery. Sunitinib and Sorafenib are medications that have been approved by the FDA for use in treating advanced kidney cancer. However, neither has been approved for use after surgery to prevent the cancer from coming back. This Phase III trial is intended to determine whether either Sunitinib or Sorafenib taken for 1 year after surgical removal of the kidney will prevent the recurrence of kidney cancer.
Patients will be randomly assigned to one of three treatment groups: Sunitinib, Sorafenib, or placebo alone. Treatment will last 1 year and patients' health and well-being will be followed for 10 years.
Eligibility (this is not a comprehensive list)
- Pre- or post-surgery patients who are at least 18 years old.
- Renal cell carcinoma (T1B, T2, T3, and T4) that has been surgically removed.
- No evidence of distant metastases or residual disease.
- No prior anti-cancer therapy
- No current malignancies other than certain skin, cervical, and breast cancers.
- No uncontrolled hypertension (high blood pressure).
- No heart attack, bypass surgery, severe/unstable angina, symptoms of congestive heart failure, or stroke in the past 6 months.
- No pregnant lactating women.
- No patients with known HIV.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about eligibility requirements, call 1-877-THR-WELL (1-877-847-9355).
|
