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    Summary
    EudraCT Number:2017-001264-38
    Sponsor's Protocol Code Number:MOU-2017-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2017-001264-38
    A.3Full title of the trial
    Sequential FDG-PET and Plasma/Tissue miRNA as a Biomarkers of Preoperative Treatment Strategy in Locally Advanced Oesophago-Gastric Cancer
    Sekvenční FDG-PET a miRNA jako biomarker změny strategie předoperační léčby u lokálně pokročilého adenokarcinomu gastroesofageální junkce a žaludku
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MOU-2017-01
    MOU-2017-01
    A.4.1Sponsor's protocol code numberMOU-2017-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMasaryk Memorial Cancer Institute
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCzech health research council
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMasaryk Memorial Cancer Institute
    B.5.2Functional name of contact pointClinical trials unit
    B.5.3 Address:
    B.5.3.1Street AddressZluty kopec 7
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code65653
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420543136232
    B.5.6E-mailstudie@mou.cz
    D. IMP Identification
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc
    lokálně pokročilý operabilní adenokarcinom oesophago-gastrického spojení T3N0, T4N0, T2-T4N+
    E.1.1.1Medical condition in easily understood language
    locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc
    lokálně pokročilý operabilní adenokarcinom oesophago-gastrického spojení T3N0, T4N0, T2-T4N+
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the FDG-PET dynamics predictive value from comparison of scans acquired (i) before initiation of preoperative chemotherapy and (ii) after first cycle of chemotherapy, through correlation of PET-based early regression with R0 resection rate.
    Primárním cílem studie je zhodnocení prediktivní hodnoty opakovaného FDG-PET jako potenciálního biomarkeru časné změny léčebné strategie vedoucí k dosažení vyššího počtu R0 resekcí. (Porovnáním obrazů pořízených před zahájením předoperační chemoterapie a po prvním cyklu) pomocí korelace časné regrese indikované PET s patologicky stanoveným TRG (tumor regression grade).
    E.2.2Secondary objectives of the trial
    1) Identification of tissue/plasma miRNAs enabling to stratify OGC patients accordingly to FDG-PET positivity.

    2) Identification of tissue/plasma miRNA panels enabling prediction of response to preoperative chemotherapy (based on TRG) through genome-wide miRNA expression profiling of biopsies/plasma samples collected (i) before initiation of the treatment and (ii) by evaluation of miRNA profiles dynamics after 14 days of the treatment.

    3) Evaluation of circulating immune cells, circulating antibody profile, tumour-bound profile in the context of FDG-PET positivity and response to chemotherapy and chemoradiotherapy, respectively.

    4) PET predictive value for DFS and OS
    1) Identifikace miRNA v tkáni/plazmě, které umožní stratifikaci pacientů s adenokarcinomem OGJ odpovídající FDG-PET pozitivitě.

    2) Identifikace miRNA panelů, které umožňují predikci odpovědi na předoperační chemoterapii (na základě TRG), pomocí profilování exprese celogenomové miRNA z biopsií/ vzorků plazmy odebraných (i) před zahájením léčby, a (ii) po 14 dnech léčby.

    3) Evaluace cirkulujících imunitních buněk, profilu cirkulujících protilátek a „tumor-bound“ profilu v kontextu FDG-PET pozitivity a potažmo odpovědi na chemoterapii a chemoradioterapii.

    4) Zhodnocení prediktivní hodnoty FGD-PET jako biomarkeru pro DFS a OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age of 18 years or more
    2. Not currently participating in another study
    3. Able and willing to sign informed consent and to comply with study procedures
    4. Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc
    I. Adenocarcinoma of distal part of the oesophagus
    II. Adenocarcinoma of the real cardia
    III. Adenocarcinoma of the subcardial stomach
    5. Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET
    6. Eligible patients have to be fit for platinum-containing chemotherapy
    7. Tumours must be potentially R0 resectable tumours during consecutive operation.
    1. Věk 18 a více let
    2. Pacient se v současné době neúčastní jiné studie
    3. Pacient je schopen a ochoten podepsat informovaný souhlas a plnit studijní postupy
    4. Biopticky potvrzený lokálně pokročilý operabilní adenokarcinom oesophago-gastrického spojení T3N0, T4N0, T2-T4N+, typ I - III dle Siewerta:
    I. Adenokarcinom distální části jícnu
    II. Adenokarcinom kardie
    III. Adenokarcinom subkardiálního žaludku
    5. Provedený staging zahrnující endoskopii, endoskopický ultrazvuk a PET/CT
    6. Pacient musí být vhodný pro chemoterapii obsahující platinu
    7. Nádor musí být potenciálně R0 operabilní při navazující operaci
    E.4Principal exclusion criteria
    1. Participation in another clinical trial of a therapeutic drug during the past 14 days
    2. Addiction to alcohol or drugs
    3. Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment
    4. Pregnant women and nursing mothers are not allowed to enroll on this study
    5. Eastern Cooperative Oncology Group score >2
    6. Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
    7. Life expectancy of less than 3 months
    8. Uncontrolled bleeding from the tumour
    9. Uncontrolled diabetes
    10. Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ
    1. Účast v lékovém klinickém hodnocení během posledních 14 dnů
    2. Závislost na alkoholu nebo drogách
    3. Ženy v plodném věku, které nepoužívají efektivní antikoncepční prostředky, (před zařazením do studie musí být u žen v plodném věku doložen negativní těhotenský test z krve)
    4. Těhotné ženy a kojící matky
    5. Eastern Cooperative Oncology Group skóre > 2
    6. Předchozí nebo sekundární maligní onemocnění v posledních 5 letech (vyjma kožního karcinomu a časného karcinomu cervixu)
    7. Očekávané přežití kratší než 3 měsíce
    8. Nekontrolované krvácení z nádoru
    9. Neléčený diabetes
    10. Pacienti nemohou být do studie zařazeni, pokud podstoupili předchozí chemoterapii, radioterapii nebo endoskopickou laserovou terapii EGJ
    E.5 End points
    E.5.1Primary end point(s)
    R0 resection rate in arm B (metabolic non-responders)
    Podíl R0 resekcí v rameni A a rameni B
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery
    Po operaci
    E.5.2Secondary end point(s)
    Disease free survival in arm A and arm B
    Overall survival in arm A and arm B
    Doba bez známek nemoci (DFS) v rameni A a v rameni B
    Celkové přežití (OS) v rameni A a v rameni B
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    5 years
    5 let
    5 let
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    poslední návštěva posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment of the condition
    Léčba po ukočnení účasti subjektu KH v KH se neliší od běžné léčby tohoto onemocnění
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CZECRIN
    G.4.3.4Network Country Czech Republic
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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