- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01754272
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Western Australia
-
Nedlands, Western Australia, Australien, 6009
- Sir Charles Gairdner Hospital
-
-
-
-
-
Leuven, Belgien, 3000
- UZ Leuven UZ Gasthuisberg 3000 Leuven
-
-
-
-
-
Sao Paulo, Brasilien, 01308050
- Hospital Sírio E Libanês
-
-
-
-
-
Odense C, Danmark, 5000
- Odense Universitetshospital
-
-
-
-
-
Moscow, Den Russiske Føderation, 115478
- NN Blokhin Russian Cancer Research Center
-
-
-
-
-
Greater London, Det Forenede Kongerige, HA6 2RN
- Mount Vernon Hospital
-
-
-
-
-
Tartu, Estland, 51014
- SA Põhja Eesti
-
-
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
-
-
-
-
-
Heraklion, Crete, Grækenland, 71110
- University Hospital Of Heraklion Voutes
-
-
-
-
-
Sittard-Geleen, Holland, 6162
- Orbis Medisch Centrum
-
-
-
-
-
Milano, Italien, 20133
- IRCCS
-
-
-
-
-
Seoul, Korea, Republikken, 138-736
- Asan Medical Center
-
Seoul, Korea, Republikken, 135-710
- Samsung Medical Center Hematology and Oncology
-
-
-
-
-
Oslo, Norge, 0407
- Oslo universitetssykehus HF
-
-
-
-
-
Cluj Napoca, Rumænien, 400015
- Spitalul Universitar CF
-
-
-
-
-
Barcelona, Spanien, 08035
- Hospital Vall d'Hebron
-
-
-
-
-
Uppsala, Sverige, 751 85
- Akademiska Sjukhuset Onkologiska Kliniken
-
-
-
-
-
Parktown, Sydafrika, 2193
- Donald Gordon Medical Centre Wits University
-
-
-
-
-
Halle, Tyskland, 06120
- Universitaetsklinikum Halle (Saale)
-
-
-
-
-
Wien, Østrig, 1090
- Medizinische Universität Wien
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Primary colorectal cancer tumor blocks
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Metastatic tumor blocks
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Residual blood samples
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sabine Tejpar, MD, PhD, KU Leuven
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ADX11080
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Metastatisk tyktarmskræft
-
University of ArkansasAktiv, ikke rekrutterendeColorectal cancer og inflammatorisk tarmsygdomForenede Stater
-
University Health Network, TorontoAstraZenecaAktiv, ikke rekrutterendeAdenocarcinom i bugspytkirtlen | Leiomyosarkom | Mismatch Reparation Proficient Colorectal CancerCanada
-
Association Pour La Recherche des Thérapeutiques...AfsluttetClear Cell Metastatic Renal Cell CarcinomaFrankrig
-
Tianjin Medical University Cancer Institute and...RekrutteringMSI-H Advanced Colorectal CancerKina
-
Sunnybrook Health Sciences CentrePfizerAfsluttetClear Cell Metastatic Renal Cell CarcinomaCanada
-
Bristol-Myers SquibbAktiv, ikke rekrutterendeMikrosatellit stabil kolorektal cancer | Mismatch Reparation Proficient Colorectal Cancer | Mikrosatellit ustabil kolorektal cancer | Mismatch Reparation Manglende tyktarmskræftForenede Stater, Australien, Belgien, Canada, Irland, Italien, Spanien, Frankrig
-
Syndax PharmaceuticalsMerck Sharp & Dohme LLCAfsluttetMelanom | Ikke-småcellet lungekræft | Mismatch Reparation-Proficient Colorectal CancerForenede Stater