AFFIRM

• Research type

  Research Study

• Full title

  Randomized, multinational, study of Aflibercept and modified FOLFOX6 as FIRst-line treatment in patients with metastatic colorectal cancer (AFFIRM)

• IRAS ID

  6816

• Sponsor organisation

  Sanofi-Aventis Research & Development

• Eudract number

  2008-004178-41

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of the study is to evaluate tumour response and progression free survival (PFS) at 12 months of modified FOLFOX6 with or without the Aflibercept in patients with metastatic colorectal cancer. Colorectal cancers among one of the most common tumour types in western countries. Although around 75 - 80% of patients present at a stage where the carcinomas can be removed via surgery almost half of patients diagnosed will die of metastatic disease. In addition around 20 - 25% of patients will present with metastatic disease. Once metastatic disease is present patients are treated with chemotherapy but the median overall survival is around 15 to 20 months. Over the past decades there have been advances in the treatments available however there still remains a need for more active treatments if we are going to improve outcomes for patients. It has been shown that some malignant tumours are dependent of the formation of new capillaries and blood vessels for nutrition and oxygen to support their growth. The formation of new blood vessels is call angiogenesis. Growth factors such as vascular endothelial growth factor or VEGF facilitate angiogenesis, therefore recent human clinical trials have focused on the use of an agent that inhibits growth factors such as VEGF in combination with standard chemotherapy and it has shown to be a positive step forward in the treatment of patients with metastatic colorectal cancer.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  08/H0904/91

• Date of REC Opinion

  24 Nov 2008

• REC opinion

  Further Information Favourable Opinion