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
- 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
- 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
After completion of study treatment, patients are followed periodically.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Cancer Research UK at Cambridge Research Institute