Early closure of a randomized trial: surgery and postoperative radiotherapy versus radiotherapy in the management of intra-oral tumours

Clin Oncol (R Coll Radiol). 1998;10(3):155-60. doi: 10.1016/s0936-6555(98)80055-1.

Abstract

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).

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / radiotherapy
  • Carcinoma, Squamous Cell / surgery
  • Cause of Death
  • Confidence Intervals
  • Disease-Free Survival
  • Dose Fractionation, Radiation
  • Follow-Up Studies
  • Humans
  • Lymph Node Excision
  • Middle Aged
  • Mouth Neoplasms / pathology
  • Mouth Neoplasms / radiotherapy
  • Mouth Neoplasms / surgery*
  • Neck Dissection
  • Neoplasm Staging
  • Neoplasm, Residual
  • Oropharyngeal Neoplasms / pathology
  • Oropharyngeal Neoplasms / radiotherapy
  • Oropharyngeal Neoplasms / surgery
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Salvage Therapy
  • Sample Size
  • Survival Rate