| Methods |
Phase II RCT; n = 74 |
| Participants |
Advanced/metastatic unresectable adenocarcinoma of colon or rectum, no prior chemotherapy |
| Interventions |
XELOX with cetuximab versus XELOX |
| Outcomes |
Primary outcome: objective response rate. No formal statistical comparisons planned. |
| Notes |
Funded by Merck, Sanofi‐Aventis, Swiss government. Follow‐up 17.2 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Randomized" ‐ no further information given |
| Allocation concealment (selection bias) |
Unclear risk |
"Randomized" ‐ no further information given |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Unclear as to blinding, but blinded review of primary outcome (see below) |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
An independent response review was conducted by 2 radiologists and 1 medical oncologist. The reviewers were blinded to the treatment arm and to the investigator's initial assessment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No dropout |
| Selective reporting (reporting bias) |
Low risk |
Declared outcomes reported. |
| Other bias |
Low risk |
No other significant bias present; funders did not have inappropriate influence. |
