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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,656
Disease-free survival
Metastasis-free survival
Disease-specific survival time
Overall survival
Cost effectiveness
Toxicity
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Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Dorset County Hospital
Dorchester, England, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
...and 29 more locations