ABSTRACT
The authors compared radiotherapy and chemoradiotherapy (cisplatin with radiotherapy) as adjuvant treatments following surgery for stage III or IV head and neck squamous cell carcinoma (HNSCC). Multicentre prospective randomised phase III trial by the EORTC Data Centre was designed to detect an absolute increase in PFS of 15% (from 40% to 55% at 3 years) with a two-sided 5% significance level and a statistical power of 80%. From February 1994 to October 2000, 334 patients from 23 institutions consented to participate in the trial; 92% were men and 69% were more than 50 years of age. These patients were randomly allocated into two groups involving X-ray radiotherapy (XRT) and carbon-ion radiotherapy (CRT), respectively. The baseline characteristics of the two groups were similar in sex, age, tumour stage, nodal stage, primary tumour site, resection margin status, histological differentiation, extracapsular spread, perineural invasion, vascular embolisms, and lymph node involvement.
