Kidney Cancer Clinical Trial
Official title:
SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after
surgery may kill any tumor cells that remain after surgery. It is not yet known whether
sorafenib is more effective than a placebo in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works
compared with a placebo in treating patients at risk of relapse after undergoing surgery to
remove kidney cancer.
OBJECTIVES:
- Compare disease-free survival of patients with resected primary renal cell carcinoma at
high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo
for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years.
OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter
study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral
placebo twice daily for 2 years in the absence of disease progression or unacceptable
toxicity.
- Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the
absence of disease progression or unacceptable toxicity.
Patients in arms I and II with progressive disease may cross over and receive treatment in
arm III.
After completion of study treatment, patients are followed periodically.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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