Skip to main content
. 2017 Jun 27;2017(6):CD007047. doi: 10.1002/14651858.CD007047.pub2

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.