Seymour PICCOLO 2013.
Methods | Phase III open‐label, multicentre RCT; n = 1198 (460 participants in Arms A and B below) | |
Participants | Advanced inoperable colorectal cancer, progressed after fluoropyrimidine chemotherapy | |
Interventions | The combination of irinotecan and panitumumab (Arm A) vs irinotecan alone (Arm B) | |
Outcomes | Primary outcome: OS. Secondary endpoints: PFS, TRR, QoL, toxicity | |
Notes | Cancer Research UK ‐ independent peer review and feedback on protocols. Amgen ‐ provided panitumumab and educational grant. Follow‐up of participants still alive (n = 41): 25.4 months |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was done with an automated telephonic system ... using a computer‐generated minimisation algorithm including a random element." |
Allocation concealment (selection bias) | Low risk | Central computer‐generated randomisation after registration |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Open‐label trial but primary outcome (OS) not affected. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary endpoint of OS |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Equal dropout (4 withdrew in arm A, 4 in arm B) |
Selective reporting (reporting bias) | Low risk | All secondary endpoints reported. |
Other bias | Low risk | No other significant bias present; funders did not have inappropriate influence. |