Aflibercept SQoP (AFLIBC06097)
Research type
Research Study
Full title
A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
IRAS ID
106289
Contact name
Ian Chau
Contact email
Sponsor organisation
Aventis Pharma Ltd. trading as sanofi
Eudract number
2011-005724-17
ISRCTN Number
xx
Research summary
Colorectal cancer is the most frequent tumour type in western countries. In the early stages of the disease patients may be treated with surgery, radiotherapy and occasionally chemotherapy. Once the cancer spreads either locally or to distant sites within the body the primary method of treatment is with chemotherapy, which is used to try and kill the cancer cells. In most cases the first type of chemotherapy given to a patient is a drug called oxaliplatin in combination with other drugs. Following progression of the disease on oxaliplatin a patient will usually be given a regimen called FOLFIRI which includes irinotecan, folinic acid anflurouracil. In the recent VELOUR trial it was shown that adding a new drug called Aflibercept to FOLFIRI increases the time it takes for a person to progress and ultimately die from their disease. Aflibercept has been submitted for a license in the USA and in Europe. This trial provides all patients with Aflibercept in combination with FOLFIRI to permit the collection of additional safety data from the VELOUR target population in the real-life setting and across geopgraphical areas and raise awareness of the anticipated toxicities for this class of drugs. In addition, the study aims to collect quality of life data, which can be used to assess the impact of Aflibercept on the patients daily quality of life and support the NICE appraisal in 2013.
REC name
London - Westminster Research Ethics Committee
REC reference
12/LO/0806
Date of REC Opinion
30 May 2012
REC opinion
Favourable Opinion