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

December 18, 2012 updated by: Prof Sabine Tejpar, KU Leuven

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

1226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven UZ Gasthuisberg 3000 Leuven
  • Brazil
      • Sao Paulo, Brazil, 01308050
        • Hospital Sírio E Libanês
  • Denmark
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • Estonia
      • Tartu, Estonia, 51014
        • SA Põhja Eesti
  • Germany
      • Halle, Germany, 06120
        • Universitaetsklinikum Halle (Saale)
  • Greece
      • Heraklion, Crete, Greece, 71110
        • University Hospital Of Heraklion Voutes
  • Italy
      • Milano, Italy, 20133
        • IRCCS
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center Hematology and Oncology
  • Netherlands
      • Sittard-Geleen, Netherlands, 6162
        • Orbis Medisch Centrum
  • Norway
      • Oslo, Norway, 0407
        • Oslo universitetssykehus HF
  • Romania
      • Cluj Napoca, Romania, 400015
        • Spitalul Universitar CF
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • NN Blokhin Russian Cancer Research Center
  • South Africa
      • Parktown, South Africa, 2193
        • Donald Gordon Medical Centre Wits University
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
  • Sweden
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset Onkologiska Kliniken
  • United Kingdom
      • Greater London, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastaic colorectal cancer who were refractory to an oxaliplatin-based chemotherapy.

Description

Inclusion Criteria:

  • Patients who have participated in the VELOUR trial

Exclusion Criteria:

  • Patients who have not participated in the VELOUR trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Sabine Tejpar, MD, PhD, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX11080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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