Terz 1981.
| Methods | Location of trial: USA. Number of centres: 2. Funding: not stated. Trial ID: not stated. |
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| Participants | Inclusion criteria: previously untreated squamous cell carcinoma Stages II‐IV of oral cavity, oropharynx or hypopharynx if disease appeared to be technically resectable. Exclusion criteria: Stage 1 disease, patients with primary tumours of lip, nasopharynx, paranasal sinuses or larynx. Recruitment period: January 1969 to September 1975. OC: 94/248 (38%). OP: 72/248 (29%). OC+OP: 166/248 (67%). Number randomised: 248. Number analysed: unclear. |
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| Interventions |
Pre‐operative radiotherapy versus surgery alone Pre‐operative radiotherapy (n = 126): 1.4 Gy in 2 equal fractions 48 and 24 hours prior to surgery. Radiotherapy administered through a pair of opposed fields to cover both primary lesion and entire cervical lymph drainage area. Co‐60 source with source to skin = 80 cm. Followed by resection of primary tumour with uni or bilateral neck dissection. Surgery alone (n = 122): resection of primary tumour with uni or bilateral neck dissection. |
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| Outcomes | Primary: complications, operative mortality. Secondary: recurrence, 5‐year disease free survival. Duration of follow‐up: 4‐9 years. |
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| Notes | HR taken from Kaplan‐Meier graph (no numbers at risk). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | No details on method of sequence generation used. Randomisation was stratified on site of primary tumour and stage of disease. |
| Allocation concealment? | Unclear risk | Not mentioned. |
| Blinding ‐ Outcome Assessors | High risk | Not mentioned. |
| Incomplete outcome data addressed? | Unclear risk | Unclear how many patients are included in the analysis as only percentages are reported. |
| Free of selective reporting? | Unclear risk | Many outcomes reported ‐ complications, operative mortality, locoregional recurrence, disease free survival. Subgroup analyses were also undertaken and it is not clear if these were preplanned. |
| Free of other bias? | Low risk | Groups appear similar at baseline. No other apparent bias. |