Early closure of a randomized trial: surgery and postoperative radiotherapy versus radiotherapy in the management of intra-oral tumours.
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).
Robertson
A G
AG
Beatson Oncology Centre, Western Infirmary, Glasgow, UK.
Soutar
D S
DS
Paul
J
J
Webster
M
M
Leonard
A G
AG
Moore
K P
KP
McManners
J
J
Yosef
H M
HM
Canney
P
P
Errington
R D
RD
Hammersley
N
N
Singh
R
R
Vaughan
D
D
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D002423:Cause of Death; D016001:Confidence Intervals; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery*; D037981:Neck Dissection; D009367:Neoplasm Staging; D018365:Neoplasm, Residual; D009959:Oropharyngeal Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D016879:Salvage Therapy; D018401:Sample Size; D015996:Survival Rate