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A Non-Interventional Follow-Up to the VELOUR Study - Translational Research

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ClinicalTrials.gov Identifier: NCT01754272
Recruitment Status : Unknown
Verified December 2012 by Prof Sabine Tejpar, KU Leuven.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Prof Sabine Tejpar, KU Leuven

Study Description
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Brief Summary:

This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who have participated in the VELOUR study.

These samples will be analysed to find proteins or markers which represent how an individual may be responding to treatment. The identification of these markers may help provide personalised and more effective treatment programs for patients with similar conditions in the future.


Condition or disease
Metastatic Colorectal Cancer

Detailed Description:

The VELOUR trial (NCT00561470) has demonstrated the efficacy of aflibercept as a second line treatment in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI)for metastatic colorectal cancer (mCRC) patients refractory to a first line oxaliplatin based chemotherapy regimen (Van Cutsem E., JCO 30 (2012):pp3499-3506). The FDA has approved Aflibercept (Zaltrap) for the treatment of metastatic colorectal cancer in combination with FOLFIRI on August 3rd 2012 and by European Medical Agency (EMEA) on November 15th 2012.

While the VELOUR study confirmed the benefits of using aflibercept in combination with FOLFIRI, the availability of biomarkers accurately predicting patients responding to this combination would further improve clinical utility of this drug. The molecular profiling of the Formaldehyde fixed paraffin embedded (FFPE) clinical tumor samples and serial plasma samples obtained from patients involved in VELOUR study and subsequent analysis of the molecular and clinical data would provide an invaluable opportunity to discover and potentially validate such biomarkers.

As blocks were not collected as part of the VELOUR trial, this protocol deals primarily with the steps that will be taken to gain ethics and consent in each of the participating countries and how the blocks will then be sourced and acquired, finally deposited in a biobank situated in KULeuven.

A VELOUR Translational Research Consortium (VTRC) has been formed by the Catholic University of Leuven (KULeuven)and Almac Diagnostics for the realisation of this study. The number of blocks available based on the surgical list held for the trial is estimated at 1030 (84% of complete trial cohort) and from a profiling viewpoint it has been calculated that the minimum number of blocks acceptable for processing and biomarker identification / validation is 500.

Due to the specific interest in angiogenesis, the VTRC consortium will aim to source blocks with both tumor and surrounding stromal tissue which will then be macro-dissected with the aim to generate data for both the tumor and surrounding angiogenic stroma. The project will generate gene expression, immunohistochemistry (IHC) and mutational data for these samples. In addition single nucleotide polymorphisms (SNP) data will be generated from non-tumor tissue, focusing on polymorphisms that demonstrate an association with disease or response outcome to therapy. Pre-processing and in silico evaluation of all data generated will support the outcome objectives of this study.

Study Design
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Study Type : Observational
Actual Enrollment : 1226 participants
Time Perspective: Retrospective
Official 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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
FOLFIRI + Aflibercept
Non-interventional study. No drugs administered. In this arm 612 patients from the VELOUR trial
FOLFIRI + Placebo
Non-interventional study. 614 patients from the FOLFIRI + placebo arm in the VELOUR trial.


Outcome Measures
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Primary Outcome Measures :
  1. Primary colorectal cancer tumor blocks [ Time Frame: Two years ]
    Identify and acquire as many archived primary tumor blocks as possible of patients with mCRC treated in The VELOUR trial. Process the acquired samples as part of a translation research program.


Secondary Outcome Measures :
  1. Metastatic tumor blocks [ Time Frame: Two years ]
    Identify and acquire as many archived metastatic tumor tissue blocks as possible of patients with mCRC treated in The VELOUR trial. Process the acquired samples as part of a translation research program.Process the acquired samples as part of a translation research program


Other Outcome Measures:
  1. Residual blood samples [ Time Frame: Two years ]
    Acess as many residual blood samples (plasma, serum) collected in the frame of the VELOUR study as possible. Process the samples to determine markers relevant to angiogenesis factors, response to aflibercept and other markers which will be defined by the steering committee.


Biospecimen Retention:   Samples With DNA
Archived FFPE (Formaldehyde fixed paraffin-embedded) primary tumour colorectal cancer tissues Archived FFPE (Formaldehyde fixed paraffin-embedded) metastatic tumour tissue Archived residual blood samples (plasma, serum) collected in the frame of the VELOUR trial

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastaic colorectal cancer who were refractory to an oxaliplatin-based chemotherapy.
Criteria

Inclusion Criteria:

  • Patients who have participated in the VELOUR trial

Exclusion Criteria:

  • Patients who have not participated in the VELOUR trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754272


Locations
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Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Sabine Tejpar, MD, PhD KU Leuven
More Information
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Responsible Party: Prof Sabine Tejpar, Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT01754272    
Other Study ID Numbers: ADX11080
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by Prof Sabine Tejpar, KU Leuven:
metastatic colorectal cancer
mCRC
Aflibercept
FOLFIRI
translational research
 retrospective
noninterventional
biomarkers
angiogenesis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases