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    Summary
    EudraCT Number:2019-003058-10
    Sponsor's Protocol Code Number:NADEJ201901
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-16
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-003058-10
    A.3Full title of the trial
    Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV)
    Prospektívna multicentrická štúdia fázy II deeskalácie primárnej chemorádioterapie skvamocelulárnych karcinómov orofaryngu (OPC) asociovaných s ľudským papiloma vírusom (HPV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NaDeJ (National Deescalation Study One)
    NáDeJ (Národná deeskalačná štúdia jedna)
    A.3.2Name or abbreviated title of the trial where available
    NaDeJ
    NáDeJ
    A.4.1Sponsor's protocol code numberNADEJ201901
    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 SponsorVÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
    B.1.3.4CountrySlovakia
    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 supportVÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
    B.5.2Functional name of contact pointOddelenia radiačnej onkológie
    B.5.3 Address:
    B.5.3.1Street AddressRastislavova 43
    B.5.3.2Town/ cityKošice
    B.5.3.3Post code041 91
    B.5.3.4CountrySlovakia
    B.5.4Telephone number+421556135511
    B.5.6E-maildubinsky@vou.sk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CISPLATIN EBEWE
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma GmbH, Nfg.KG (AUT)
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecisplatina
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINA
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive namecisplatina
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cisplatin Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited (GBR)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecisplatina
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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
    Human Papillomavirus oropharyngeal squamous cell carcinoma
    Skvamocelulárny karcinóm orofaryngu asociovaný s ľudským papiloma vírusom
    E.1.1.1Medical condition in easily understood language
    Cancer of the throat associated with HPV
    Karcinóm hrdla asociovaný s HPV
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assesment of primary CRT de-escalation effectiveness in achieving two-year local disease control and late toxicity prevalence evaluated by CTC AE v.4 and PRO CTC v 4.
    Hodnotenie efektivity deeskalácie primárnej CRT v zmysle dosiahnutia 2-ročnej lokoregionálnej kontroly ochorenia a prevalencie neskorej toxicity hodnotenej pomocou CTC AE v.4 a PRO CTC v 4.
    E.2.2Secondary objectives of the trial
    Assessment of relapse-free and overall survival,
    Assessment of acute toxicity and compliance with treatment,
    Analysis of results according to known prognostic factors including smoking,
    Assesment of PRO in terms of quality of life before and after treatment using validated questionnaires,
    Assesment of the impact of treatment on sexual life using a validated questionnaire,
    Standardization of RT OPC planning in participating centers,
    Dosimetric risk analysis of xerostomy and dysphagia,
    Central assessment of p16 status and its correlation with a specific test aimed at identifying HPV oncogenes,
    Molecular profile and genomic analysis of tumors in non-smokers and smokers,
    Assessment of negative predictive value of PETCT after CRT.
    Hodnotenie prežívania bez recidívy a celkového prežívania,
    Hodnotenie akútnej toxicity a kompliancie s liečbou,
    Analýza výsledkov podľa známych prognostických faktorov vrátanie fajčenia,
    Hodnotenie PRO v zmysle kvality života pred a po liečbe pomocou validovaných dotazníkov,
    Hodnotenie vplyvu liečby na sexualitu pomocou validovaného dotazníka,
    Štandardizácia plánovania RT OPC v zúčastnených centrách,
    Dozimetrická analýza rizika xerostómie a dysfágie,
    Centrálne hodnotenie p16 statusu a jeho korelácia s viac špecifickým testom zameraným na identifikáciu HPV onkogénov,
    Molekulový profil a genómová analýza nádorov u nefajčiarov a fajčiarov,
    Hodnotenie negatívnej prediktívnej hodnoty PETCT po CRT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Oropharyngeal squamous cell carcinoma
    • Positivity of p16 by imunohistochemistry
    • Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases
    • The lifetime cumulative history of smoking cannot exceed 20 packages / years
    • WHO status 0-1
    • Age ≥ 18 years
    • Both genders
    • Hemoglobin ≥ 10 g/l
    • Platelets ≥1 00x 10x9/l
    • Neutrophils ≥ 1,5 x 10x9/l
    • Adequate renal functions enable one-week therapy of cisplatina
    • Bilirubin, AST or ALT 3x upper limit of norm
    • Negative pregnancy test
    • Signed informed consent
    • Slovak language
    • Diagnóza skvamocelulárneho karcinómu (SCC) orofaryngu
    • Pozitivita odobratého tkaniva p16 imunohistochemickým vyšetrením
    • Klinické štádium T1-T2, N1-N2c alebo T3, N2-N2c, UICC 8. vydanie bez vzdialených metastáz
    • Celková celoživotná história fajčenia nesmie prekročiť 20 balení / rokov
    • WHO výkonnostný stav 0-1
    • Vek ≥ 18 rokov
    • Obe pohlavia
    • Hemoglobín ≥ 10 g/l
    • Trombocyty ≥1 00x 10x9/l
    • Neutrofily ≥ 1,5 x 10x9/l
    • Adekvátne renálne funkcie umožňujúce podanie týždennej cisplatiny
    • Bilirubín, AST alebo ALT ˂ 3x vyšší limit normy
    • Negatívny test tehotenstva u fertilných žien
    • Podpísaný informovaný súhlas
    • Slovenčina
    E.4Principal exclusion criteria
    • Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
    • Tumor of unknown origin (p16 positivity too)
    • Simultaneous tumors
    • Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years
    • Previous radiotherapy in the head and neck area to overlap the irradiated volume
    • Unstable angina or congestive heart failure requiring hospitalization for the last 6 months
    • Transmural myocardial infarction last 6 months
    • Active infection requiring i.v. antibiotics at the time of registration
    • Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment
    • Hepatic insufficiency with clinical jaundice and impaired coagulation
    • Active AIDS disease, but the protocol does not require HIV testing
    • Pregnancy
    • Previous allergic reaction to cisplatin
    • Nádor nachádzajúci sa v ústnej dutine alebo v nosohltane alebo v hypofaryngu alebo laryngu ak je aj p16 pozitívny
    • Karcinóm neznámeho pôvodu na krku (aj ak je p16 pozitívny)
    • Simultánne nádory
    • Pacienti s invazívnou malignitou (okrem nemelanómového karcinómu kože) a anamnézou diagnózy nádoru kratšou ako 3 roky
    • Predchádzajúca rádioterapia v oblasti hlavy a krku, ktorá by znamenala prekrývanie ožarovaného objemu
    • Nestabilná angína alebo kongestívne zlyhanie srdca vyžadujúce si hospitalizáciu posledných 6 mesiacov
    • Transmurálny infarkt myokardu posledných 6 mesiacov
    • Aktívna infekcia vyžadujúca si i.v. antibiotiká v čase registrácie
    • Chronická obštrukčná bronchoplumonálna choroba s exacerbáciou alebo iné respiračné ochorenie vyžadujúce si hospitalizáciu alebo odloženie štúdiovej liečby v rámci 30 dní pri registrácii
    • Hepatálna insufiencia s klinickou žltačkou a porušenou koaguláciou
    • Aktívne ochorenie AIDS, avšak protokol si HIV testovanie nevyžaduje
    • Tehotenstvo
    • Predchádzajúca alergická reakcia na cisplatinu
    E.5 End points
    E.5.1Primary end point(s)
    Two-year locoregional control
    Dvoj-ročná lokoregionálna kontrola
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 roky
    E.5.2Secondary end point(s)
    Primary loco-regional control after initial intervention and CRT
    Overall survival
    Disease-specific survival
    Survival without disease
    Percentage of distant metastases
    Adverse effects
    Influencing QoL
    Reliability and validity of biomarker p16
    Difference in OPC-associated HPV molecular profile in non-smokers and smokers
    Primárna loko-regionálna kontrola po úvodnej intervencii a CRT
    Celkové prežívanie
    Prežívanie špecifické pre ochorenie
    Prežívanie bez recidívy
    Podiel vzdialených metastáz
    Nežiaduce účinky
    Ovplyvnenie QoL
    Spoľahlivosť a validita biomarkera p16
    Rozdiel v molekulovom profile HPV asociovaných OPC u nefajčiarov a fajčiarov
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 roky
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.8.3 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
    Posledná návšteva posledného subjektu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 120
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-09-16. Yes
    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 state120
    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)
    Patients will continue to receive clinical follow-up in accordance with local procedures.
    Pacienti budú pokračovať v klinickom sledovaní v súlade s miestnymi postupmi.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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