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. 2018 Dec 24;2018(12):CD006205. doi: 10.1002/14651858.CD006205.pub4

Iyer 2015.

Methods Location of trial: Singapore
Number of centres: not stated
Funding: not stated
Trial ID: not stated
Participants Inclusion criteria: people newly diagnosed with histologically confirmed, resectable, non‐metastatic stage III/IV HNSCC who had a good Eastern Cooperative Oncology Group performance status (0 or 1) and adequate bone marrow, hepatic and renal function.
Exclusion criteria: nasopharynx and salivary glands
Recruitment period: August 1996 to February 2002
Number randomised: 119
Number analysed: 118
Interventions Surgery and adjuvant RT vs concurrent CRT
Group 1 (n = 60): radical surgery + adjuvant RT
Group 2 (n = 59): combination chemotherapy with cisplatin and 5‐fluorouracil and concurrent RT
Randomisation was stratified according to primary tumour site (oral cavity/oropharynx, larynx/hypopharynx, others) and lymph node status (lymph‐node positive vs lymph‐node negative).
Outcomes To determine whether concurrent chemotherapy was superior to the prevailing conventional treatment at that time, namely surgery and adjuvant RT, with survival as the endpoint.
Primary: overall survival, DSS, locoregional recurrence‐free survival, distant recurrence‐free survival
Secondary: none noted
Duration of follow‐up for all participants: 10 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described.
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Survival was primary outcome and considered an objective outcome.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Only 1 participant missing from analysis as histopathological assessment confirmed adenocarcinoma, therefore excluded.
Selective reporting (reporting bias) Low risk No evidence of selective outcome reporting.
Other bias Low risk No other apparent bias.