A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982

2004 
4517 Background: Adjuvant radiotherapy is effective treatment for stage I seminoma, but is associated with a late risk of 2nd cancers. The MRC has undertaken two trials to reduce adjuvant radiation dose (TE18: 30Gy vs 20Gy) and volume (TE10: PA strip vs dog-leg field) without loss of effectiveness. Following reports that 1 course of carboplatin (C) may be equivalent to radiation (R) this large randomised trial was undertaken to compare these approaches; we present the initial results of this study. Methods: The primary randomisation was between R and 1 course of C AUCx7; R dose was optionally decided by randomisation between 20 Gy/10f and 30 Gy/15f prior to results of TE18, or centre choice of schedule. The trial was powered to exclude absolute differences in the 2 year relapse rates of >3%. Results: From June 96 to March 01 1447 patients (pts) were randomised (ratio 3:5) between C and R. Pt characteristics were well balanced: mean age 38 years, 14% had elevated HCG and 10% had previous ipsilateral inguin...
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