Non-Interventional Follow-Up to VELOUR trial: Translational research
Research type
Research Study
Full title
A Non-Interventional Follow-Up to the VELOUR study (multicentre international study of aflibercept versus placebo in combination with FOLFIRI for metastatic colorectal cancer) – Translational Research
IRAS ID
120021
Contact name
Robert Glynne-Jones
Contact email
Sponsor organisation
Katholieke Universiteit Leuven
Research summary
This study is a multinational academic translational follow-up study to the VELOUR Phase III clinical trial. This trial assessed the benefit of vascular epithelial growth factor (VEGF) Trap Aflibercept in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) for second line therapy of metastatic colorectal cancer (mCRC).
The study is being performed as the Phase III trial demonstrated a positive outcome to those patients treated with Aflibercept in combination with FOLFIRI versus placebo with FOLFIRI. The objective of this study is to collect primary tissue from patients recruited to the VELOUR trial for analyses for research that will provide further insight into the pathogenesis and biology of colorectal cancer as well as to provide the basis of identifying biomarkers of response to Aflibercept to support future use in the clinical management of mCRC. Gene expression, pathology review, mutational status and immunohistochemistry (IHC) data shall be generated using these tissue samples.
A secondary research objective of the study is to review current thinking around colorectal cancer tissue morphology and its correlation with disease and genomic data output.
The scope of this study is to collect and biobank tumour tissue archived following the primary surgery/surgeries of patients recruited to the clinical trial. The result will be the generation of a unique suite of molecular analyses associated with a detailed pathological and clinical annotated database which will serve as an invaluable resource for the understanding of the mechanisms underlying angigogenesis, the pathogenesis of metastatic colorectal cancer and the discovery of biomarkers of response to anti-angiogenic therapies such as aflibercept.
The study is sponsored by the Katholieke Universiteit Leuven (KULeuven) working in partnership with Almac (contract research organisation, CRO) as the VELOUR Translational Research Consortium (VTRC).
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
13/NE/0210
Date of REC Opinion
13 Jul 2013
REC opinion
Favourable Opinion