Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to estimate the progression-free survival rate at 12
months for the two arms of the study.
Secondary objectives include the evaluation of overall objective response rate to treatment,
progression-free survival, overall survival, safety and documentation of potential
immunogenicity of aflibercept.
This study was a non-comparative randomized trial and was not powered for a comparison of any
of the efficacy endpoints.
Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and
safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of
non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a
check on the similarity of the current patients to the historical controls with respect to
clinical outcome when given FOLFOX6 treatment.