Yuen 2009.
Methods | Location of trial: Hong Kong, China Number of centres: 3 Funding: not stated Trial ID: not stated |
|
Participants | Inclusion criteria: AJCC, Stage I to II, SCC oral tongue; no nodal metastases; no prior surgery, chemotherapy or RT Exclusion criteria: OC of other subsites, or cancer of base of tongue Recruitment period: 1996–2004 Numbers randomised: 72 (all OC: 100% tongue) Numbers analysed: 71 |
|
Interventions |
Elective selective ND vs therapeutic radical ND Group 1 (n = 36): elective ipsilateral selective ND of level I, II or III neck nodes. Group 2 (n = 36): therapeutic (delayed) dissection. These participants were followed, and received ultrasound examinations every 3 months for the first 3 years. If nodal recurrence was detected, these participants underwent either radical or modified radical ND followed by RT. All participants in the trial had transoral glossectomy with 1.5 resection margins. |
|
Outcomes | Primary: nodal recurrence, disease recurrence, death due to tumour, 5‐year tumour‐specific survival Duration of follow‐up: 34–122 months |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation stratified by tumour stage. Method of sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Used sealed envelopes to contain the allocation. Insufficient information to determine whether allocation was concealed from investigators. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Mortality was primary outcome and considered an objective outcome. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant allocated to observation group was subsequently found to have T3 tumour and was withdrawn. All other randomised participants included in the outcome evaluations. |
Selective reporting (reporting bias) | High risk | Reported nodal and local recurrence, DFS and disease‐specific death. No reporting of mortality in each group. |
Other bias | Low risk | Groups appeared similar at baseline. |
AJCC: American Joint Committee on Cancer; CRT: chemoradiotherapy; CT: computer tomography; DFS: disease‐free survival; DSS: disease‐specific survival; FOM: floor of mouth; HNSCC: head and neck squamous‐cell carcinoma; HR: hazard ratio; MRI: magnetic resonance imaging; MRND: modified radical classical neck dissection; n: number of participants; NCR: neck control rate; ND: neck dissection; OC: oral cancer; OP: oropharyngeal cancer; PET‐CT: positron‐emission tomography–computed tomography; PORT: postoperative radiotherapy; RMT: retromolar trigone; RT: radiotherapy; SCC: squamous‐cell carcinoma; SE: standard error; SOH: supraomohyoid neck dissection.