A Non-Interventional Follow-Up to the VELOUR Study - Translational Research
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- Sir Charles Gairdner Hospital
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Leuven, Belgien, 3000
- UZ Leuven UZ Gasthuisberg 3000 Leuven
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Sao Paulo, Brasilien, 01308050
- Hospital Sírio E Libanês
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Odense C, Danmark, 5000
- Odense Universitetshospital
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Tartu, Estland, 51014
- SA Põhja Eesti
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
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Heraklion, Crete, Grekland, 71110
- University Hospital Of Heraklion Voutes
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Milano, Italien, 20133
- IRCCS
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Seoul, Korea, Republiken av, 138-736
- Asan Medical Center
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Seoul, Korea, Republiken av, 135-710
- Samsung Medical Center Hematology and Oncology
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Sittard-Geleen, Nederländerna, 6162
- Orbis Medisch Centrum
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Oslo, Norge, 0407
- Oslo Universitetssykehus HF
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Cluj Napoca, Rumänien, 400015
- Spitalul Universitar CF
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Moscow, Ryska Federationen, 115478
- NN Blokhin Russian Cancer Research Center
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Barcelona, Spanien, 08035
- Hospital Vall d'hebrón
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Greater London, Storbritannien, HA6 2RN
- Mount Vernon Hospital
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Uppsala, Sverige, 751 85
- Akademiska Sjukhuset Onkologiska Kliniken
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Parktown, Sydafrika, 2193
- Donald Gordon Medical Centre Wits University
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Halle, Tyskland, 06120
- Universitaetsklinikum Halle (Saale)
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Wien, Österrike, 1090
- Medizinische Universität Wien
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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FOLFIRI + Aflibercept
Non-interventional study.
No drugs administered.
In this arm 612 patients from the VELOUR trial
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FOLFIRI + Placebo
Non-interventional study.
614 patients from the FOLFIRI + placebo arm in the VELOUR trial.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Primary colorectal cancer tumor blocks
Tidsram: Two years
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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.
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Two years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Metastatic tumor blocks
Tidsram: Two years
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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
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Two years
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Residual blood samples
Tidsram: Two years
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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.
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Two years
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sabine Tejpar, MD, PhD, KU Leuven
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ADX11080
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