Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer (CULTURE3D)
4. april 2018 opdateret af: Institut Curie
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study
Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.
Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30).
Results from this chemogram will not interfere with the treatment combination choice.
The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Paris, Frankrig, 75005
- Institut Curie
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Paris, Frankrig, 75475
- Hôpital Lariboisière
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged 18 years old or more
- Colorectal cancer with synchronous or metachronous metastases
- Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
- Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
- Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
- No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion.
- Life expectancy > 3 months (ECOG 0-1-2).
- Informed and signed consent by the patient.
Exclusion Criteria:
- Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease
- Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
- Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
- Patient already enrolled in an other clinical trial with another first line of chemotherapy.
- Pregnant women, breastfeeding or of childbearing age not taking contraceptive
- Persons deprived of liberty.
- Subject unable to make follow up schedule
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: biopsy to obtain a chemogram
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All patients enrolled will have biopsies (on primary tumor or on a metastasis) before treatment in order to obtain a chemogram by ex vivo 3D culture cells
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of interpretable chemogram
Tidsramme: through study completion, an average of 1 year
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In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.
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through study completion, an average of 1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.
Tidsramme: through study completion, an average of 1 year
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Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.
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through study completion, an average of 1 year
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Chemosensitivity evaluated on 3D culture.
Tidsramme: through study completion, an average of 1 year
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on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.
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through study completion, an average of 1 year
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time to obtain chemogram
Tidsramme: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pascale Mariani, MD, Institut Curie
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2011
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først indsendt
13. juli 2016
Først indsendt, der opfyldte QC-kriterier
26. juli 2016
Først opslået (Skøn)
29. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IC 2009-08
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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