Iyer 2015.
Methods | Location of trial: Singapore Number of centres: not stated Funding: not stated Trial ID: not stated |
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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 |
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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). |
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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 |
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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. |