5040 Background: Despite an apparently curative resection, 30% of patients with RCC will develop metastases. Histological risk factors can predict those at highest risk. The role of adjuvant treatment remains unclear. The aim of the present study was to determine if triple therapy improves disease free (dfs) or overall survival (os). Methods: Patients 8 weeks post nephrectomy for RCC without macroscopic residual disease with stage T3b-c,T4 or any pT and pN 1 or pN 2 or positive microscopic margins or microscopic vascular invasion, and no metastases were randomised to receive either adjuvant treatment (regimen in table below) or to observation only. Quality of life was assessed by EORTC QLQ C-30. Treatment delivery and toxicity were monitored. The trial was designed to detect an increase in 3 year dfs from 50 % in controls to 65 % on treatment (hazard ratio (HR)=0.63) with 90% power and 2-sided alpha = 0.05; this requires 308 patients and 200 events. Preliminary data release has been approved by the IDMC. ...