| Methods | RCT (Randomised Controlled Trial); multicentre (Netherlands) | |
| Participants | Patients with Dukes´B and C (TNM stage II‐III) colon (n=730) and rectal (n=299) cancer undergoing radical surgery of the primary tumour (n=1029) | |
| Interventions | 2‐arm trial: patients were randomly assigned to: A) surgery alone (n=515), or B) surgery + adjuvant chemotherapy (n=514) with 5‐FU plus levamisole | |
| Outcomes | Disease‐free survival (DFS) and overall survival (OS) | |
| Notes | More than 50% of patients with rectal cancer underwent radiotherapy. No stratification between Dukes B and C. For this meta‐analysis, patients with rectal cancer treated with surgery alone (n=150) were compared to those undergoing surgery + adjuvant chemotherapy (n=149) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Blinding (performance bias and detection bias) All outcomes | Low risk | |
| Other bias | Low risk | |
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