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

Sponsor

KU Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT01754272

Collaborator

(none)

1,226

Enrollment

Locations

Duration (Months)

61.3

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

Primary colorectal cancer tumor blocks [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

Metastatic tumor blocks [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

Residual blood samples [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who have participated in the VELOUR trial

Exclusion Criteria:

Patients who have not participated in the VELOUR trial

Contacts and Locations

Locations

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