Conditions: Colorectal Neoplasms Neoplasm Metastasis
Keywords: Angiogenesis Colon cancer Rectal cancer Oxaliplatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 268
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: modified FOLFOX6 chemotherapy regimen arm 2: modified FOLFOX6 chemotherapy regimen in combination with aflibercept

Interventions: intervention 1: aflibercept intervention 2: oxaliplatin intervention 3: 5-FU intervention 4: Folinic Acid
Intervention descriptions: intervention 1: administration: IV infusion intervention 2: administration: IV infusion intervention 3: administration: IV infusion intervention 4: administration: IV infusion

Protocol document: