Leborgne 1995.
Methods | RCT 1995‐2004 |
|
Participants | 340 patients Stage IB2 to IVB |
|
Interventions | Radiotherapy versus concomitant chemoradiotherapy (Cisplatin, 5‐FU) | |
Outcomes | Survival, disease‐free survival, local and distant recurrence | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Data checks on IPD provided suggest adequate sequence generation |
Allocation concealment (selection bias) | Low risk | Sealed envelope |
Blinding (performance bias and detection bias) All outcomes | High risk | Trial was not blinded due to nature of treatment interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | IPD provided for all outcomes except acute toxicity and late toxicity |
Selective reporting (reporting bias) | Low risk | N/A (IPD supplied for all outcomes except acute toxicity and late toxicity) |
Other bias | Low risk | Data checks on IPD provided suggest study is free of follow‐up bias |