Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
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ABSTRACT: 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.
DISEASE(S): Metastatic Colorectal Cancer,Neoplasm Metastasis,Colon Cancer,Colorectal Cancer Metastatic,Colorectal Neoplasms,Neoplasms
PROVIDER: 2068501 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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