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Medline ® Abstract for Reference 4

of 'Treatment of locoregionally advanced (stage III and IV) head and neck cancer: The oral cavity'

Early closure of a randomized trial: surgery and postoperative radiotherapy versus radiotherapy in the management of intra-oral tumours.
Robertson AG, Soutar DS, Paul J, Webster M, Leonard AG, Moore KP, McManners J, Yosef HM, Canney P, Errington RD, Hammersley N, Singh R, Vaughan D
Clin Oncol (R Coll Radiol). 1998;10(3):155.
Tumours of the oral cavity/oropharynx occur relatively infrequently in the UK. The management of such lesions, especially the squamous cell carcinomas, is still a little controversial. Some centres advocate radiotherapy while others adopt surgery and radiotherapy. In an attempt to resolve the question of which approach gives the better results, a multicentre randomized trial was established to compare surgery plus postoperative radiotherapy with radical radiotherapy alone. It was anticipated that 350 patients would be required to give a statistically significant result, but, after 35 patients had been entered, the trial was closed prematurely with a marked difference in overall survival in favour of the combination arm (P = 0.0006). At this analysis, carried out 23 months after trial closure, the survival difference between the two arms remains statistically significant for all causes of mortality (P = 0.001; relative death rate = 0.24; 95% CI 0.10-0.59).
Beatson Oncology Centre, Western Infirmary, Glasgow, UK.