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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01754272
• Other study ID #: ADX11080
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2012
• Last updated: December 18, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1226
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have participated in the VELOUR trial

Exclusion Criteria:

• Patients who have not participated in the VELOUR trial

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Austria	Medizinische Universität Wien	Wien
Belgium	UZ Leuven UZ Gasthuisberg 3000 Leuven	Leuven
Brazil	Hospital Sírio E Libanês	Sao Paulo
Denmark	Odense Universitetshospital	Odense C
Estonia	SA Põhja Eesti	Tartu
Germany	Universitaetsklinikum Halle (Saale)	Halle
Greece	University Hospital Of Heraklion Voutes	Heraklion, Crete
Italy	IRCCS	Milano
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center Hematology and Oncology	Seoul
Netherlands	Orbis Medisch Centrum	Sittard-Geleen
Norway	Oslo Universitetssykehus HF	Oslo
Romania	Spitalul Universitar CF	Cluj Napoca
Russian Federation	NN Blokhin Russian Cancer Research Center	Moscow
South Africa	Donald Gordon Medical Centre Wits University	Parktown
Spain	Hospital Vall d'Hebrón	Barcelona
Sweden	Akademiska Sjukhuset Onkologiska Kliniken	Uppsala
United Kingdom	Mount Vernon Hospital	Greater London
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Denmark,  Estonia,  Germany,  Greece,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual blood samples	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	No
Primary	Primary colorectal cancer tumor blocks	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	No
Secondary	Metastatic tumor blocks	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	No